AppliedXL News

Otsuka's centanafadine faces July 24 FDA decision for adult ADHD

Wed, 15 Jul 2026 21:18:51 GMT

The priority-review verdict on Otsuka's serotonin-norepinephrine-dopamine reuptake inhibitor rests on two pivotal trials that already met their primary endpoint against placebo.

Otsuka's centanafadine faces July 24 FDA verdict after positive ADHD anxiety data

Wed, 15 Jul 2026 21:17:58 GMT

The FDA reviews centanafadine for ADHD under Priority Review as Otsuka's separate Phase 3b trial in comorbid anxiety just cleared its endpoint, adding supportive data ahead of the decision.

Regeneron's garetosmab nears FDA verdict on 94% HO-lesion cut in FOP

Wed, 15 Jul 2026 21:17:24 GMT

The FDA is due to rule on garetosmab by the end of August 2026, weighing a Priority Review BLA built on OPTIMA's Phase 3 lesion-reduction data against a trial whose primary endpoint was safety, not lesion count.

GSK's bepirovirsen heads to FDA decision on positive Phase 3 cure data

Wed, 15 Jul 2026 21:16:30 GMT

The October 26 PDUFA date tests whether two positive Phase 3 trials translate into the first approved functional-cure therapy for chronic hepatitis B.

Ultragenyx's DTX401 gene therapy faces FDA priority review verdict August 23

Wed, 15 Jul 2026 21:15:20 GMT

The FDA's Priority Review decision on DTX401 would deliver the first therapy addressing GSDIa's underlying enzyme deficiency, resting on a 49-patient Phase 3 that already met its primary endpoint.

Ocugen's OCU400 heads toward a 2026 EMA filing decision in retinitis pigmentosa

Wed, 15 Jul 2026 21:13:56 GMT

Ocugen says its gene therapy remains on track for EMA marketing authorization this year, even as the Phase 3 trial backing the filing pushed its completion date out to 2027.

ENDURANCE trial: two years of lenalidomide matches lifelong maintenance in myeloma

Wed, 15 Jul 2026 21:00:00 GMT

The ECOG-ACRIN Phase 3 trial found near-identical seven-year survival with fixed two-year lenalidomide versus indefinite therapy, while indefinite dosing carried more toxicity and second cancers.

Chia Tai Tianqing opens China trial testing adalimumab in pediatric uveitis

Wed, 15 Jul 2026 15:55:30 GMT

The Phase 4 study measures time to treatment failure in children with non-infectious uveitis, a setting where adalimumab already has one completed Chinese cohort behind it.

Karyopharm's decade-old selinexor myeloma trial re-opens enrollment for a new arm

Wed, 15 Jul 2026 15:55:28 GMT

STOMP resumed recruiting to test selinexor plus the CELMoD mezigdomide, its 12th combination arm, after a completion date that has slipped nearly seven years since 2020.

M.D. Anderson prostate trial reopens enrollment after March closeout

Wed, 15 Jul 2026 15:54:55 GMT

The Nautilus lutetium trial swung from Active-not-recruiting back to Recruiting four months after cutting its enrollment target from 36 to 6.

Chia Tai Tianqing opens China Phase 2 of JAK2 drug TQ05105 in myelofibrosis

Wed, 15 Jul 2026 15:45:04 GMT

The 51-patient trial begins recruiting after a prior JAK2 program combination was terminated, testing whether TQ05105 alone can hit a 35% spleen-volume reduction bar in intermediate/high-risk myelofibrosis.

SHY Therapeutics starts Phase 1 dose-finding trial of proteasome inhibitor SHY-ONC6

Wed, 15 Jul 2026 15:35:15 GMT

The 30-patient study will test dose-limiting toxicity and a recommended Phase 2 dose in a tumor field where proteasome inhibition has run mostly in blood cancers.

Endevica's cachexia trial pushes primary readout to October 2027, third delay

Wed, 15 Jul 2026 15:35:04 GMT

The Phase 2 mifomelatide study has slipped its completion date three times since 2025, an 760-day cumulative delay, while enrollment target and design stay unchanged.

CSPC Ouyi opens dosing in Phase 1 trial of injectable pain drug SYH9089

Wed, 15 Jul 2026 15:35:02 GMT

The China-based trial moved from not-yet-recruiting to recruiting, with a safety readout due by year end that will test whether the injectable holds up against a crowded field of postoperative-pain drugs.

Beijing Gene Key registers Phase 1 test of allogeneic cell therapy GKL-006Allo

Wed, 15 Jul 2026 15:25:46 GMT

The China-based trial will test safety and dose-limiting toxicity of an allogeneic cell injection in pretreated tumors, with no disclosed molecular target yet to benchmark it against rivals.

FutureGen pairs two CLDN18.2 antibodies in new China -tumor trial

Wed, 15 Jul 2026 15:25:46 GMT

The Phase I/II combination of FG-M108 and FG-B901 tests whether stacking two CLDN18.2-targeted antibodies adds benefit beyond FutureGen's own single-agent program already in Phase 3.

Suncadia tests TNF blocker adalimumab as adjunct in resectable lung cancer

Wed, 15 Jul 2026 15:25:27 GMT

A Phase 2 trial pairs the decades-old anti-inflammatory antibody with unnamed anti-tumor therapy, betting pathological complete response can rise in operable non-small cell lung cancer.

Jiangsu HengRui starts Phase 3 KRAS G12D pancreatic cancer trial, only one of its kind

Wed, 15 Jul 2026 15:25:18 GMT

HRS-4642 becomes the sole Phase 3 asset in KRAS G12D pancreatic cancer as Jiangsu HengRui moves the 588-patient trial into recruiting, testing whether the target's promise translates to survival benefit.

Shenzhen Core Medical opens 6-patient trial of percutaneous right-heart pump

Wed, 15 Jul 2026 15:25:11 GMT

The device-feasibility study will test whether CorVad can support patients in refractory right heart failure through explant, with survival as the primary measure.

Vigonvita plans Phase 2 test of VV119 against PANSS in acute schizophrenia

Wed, 15 Jul 2026 15:25:07 GMT

The China-based trial will measure PANSS symptom change at week 6 in 500 patients, entering a schizophrenia field led by muscarinic and TAAR1 mechanisms already in Phase 3.

Peg-Bio opens 8-patient Phase 2 test of FT1 in short bowel syndrome

Wed, 15 Jul 2026 15:25:04 GMT

The trial measures fecal wet weight against baseline in a metabolic balance study, entering a field where GLP-2 drugs already dominate.

Orasis and Aspen file BESKA for presbyopia in Australia on approved Phase 3 data

Wed, 15 Jul 2026 13:15:00 GMT

The NDA leans on NEAR-1 and NEAR-2 results already behind BESKA's U.S. approval, making replication of that Day 8 near-vision gain the bar for Australian regulators, not a new efficacy question.

Nutrafol study links its supplement to 19%-37% faster hair growth in women

Wed, 15 Jul 2026 13:04:00 GMT

A peer-reviewed 180-woman study found Nutrafol's Hair Growth Nutraceuticals associated with faster linear hair growth at 6 months, an endpoint rarely measured in hair-thinning research.

Ractigen's RAG-17 cuts SOD1 protein 69% in six-patient ALS trial

Wed, 15 Jul 2026 12:47:00 GMT

Published Phase 1 data show the siRNA candidate hit its safety endpoint with no serious adverse events, while CSF SOD1 fell 69% and plasma NfL fell 62% in a first-in-human cohort of six.

NeuroThera opens German site for SCI-110 Tourette trial, cites unverified 21% tic drop

Wed, 15 Jul 2026 12:41:00 GMT

The Phase IIb expansion leans on a Phase IIa topline figure that still carries no sample size, p-value, or timepoint, leaving the placebo-controlled trial to supply the first rigorous test.

aTyr's efzofitimod misses again on steroids in sarcoidosis lung subgroup

Wed, 15 Jul 2026 12:34:58 GMT

A 44-patient post hoc slice of the failed Phase 3 EFZO-FIT trial shows an FVC gain that is now anchoring aTyr's next registrational study, not the original steroid-sparing goal.

Allogene's ALLO-316 hits 31% response rate in CD70-high kidney cancer

Wed, 15 Jul 2026 12:30:00 GMT

Complete Phase 1 TRAVERSE data show durable responses with an allogeneic CAR T in a population that had exhausted checkpoint inhibitors and TKIs, though the trial remains a 51-patient, uncontrolled study.

Kairos reports no severe toxicity in 13 patients on carotuximab-osimertinib combo

Wed, 15 Jul 2026 12:30:00 GMT

The Phase 1 trial's primary endpoint is dose-limiting toxicity, and safety data so far do not report efficacy on the resistance-reversal thesis the company is pitching.

Profound Medical to present CAPTAIN safety data on TULSA vs. prostatectomy at SRS2026

Wed, 15 Jul 2026 12:05:08 GMT

The randomized trial's primary completion date has already slipped a year, and the July 26 session is billed as safety outcomes, not the efficacy result investors are waiting on.

Profound Medical's CAPTAIN trial to present TULSA safety data vs prostatectomy

Wed, 15 Jul 2026 12:05:01 GMT

The randomized CAPTAIN trial presents primary safety outcomes for the TULSA ablation procedure against radical prostatectomy, four years into a trial whose completion date has already slipped a year.

Rani's oral RT-114 tops matched injected dose, no drug-related AEs in Phase 1a

Wed, 15 Jul 2026 12:00:00 GMT

A 30-person healthy-volunteer cohort shows Rani Therapeutics' RaniPill-delivered GLP-1/2 agonist clearing subcutaneous exposure, positioning a repeat-dose obesity study for 2026.

InnoCare's soficitinib hits both co-primary endpoints in Phase 3 atopic dermatitis trial

Wed, 15 Jul 2026 11:54:25 GMT

The oral TYK2 inhibitor cleared vIGA-AD and EASI-75 goals with no new safety signals, but InnoCare has not yet released the effect sizes that would size the win against approved JAK1 rivals.

Toripalimab surgery data show fewer canceled operations in NEOTORCH

Wed, 15 Jul 2026 11:33:00 GMT

A post hoc analysis of the Neotorch trial ties perioperative toripalimab to lower surgery-cancellation rates and deeper tumor downstaging, both linked to longer event-free survival.

Cellectar's iopofosine data show 15.4% response rate in myeloma Phase 1

Wed, 15 Jul 2026 11:30:00 GMT

A published dose-escalation study in heavily pretreated myeloma patients set a maximum tolerated dose and pointed to a fractionated regimen for further testing, six years after the trial finished enrolling.

Merck to present ISLEND-2 Week 48 data confirming weekly ISL/LEN met endpoint

Wed, 15 Jul 2026 11:25:58 GMT

The Phase 3 readout already showed the switch regimen held HIV-1 suppression at Week 48; AIDS 2026 delivers the full efficacy and safety data behind that result.

Merck to unveil Week 24 data on weekly islatravir/ulonivirine at AIDS 2026

Wed, 15 Jul 2026 11:25:30 GMT

The Phase 2b readout tests whether a once-weekly pill can hold viral suppression as well as daily BIC/FTC/TAF, Merck's established switch regimen.

Gilead's weekly islatravir/lenacapavir met HIV suppression goal versus Biktarvy

Wed, 15 Jul 2026 11:25:28 GMT

ISLEND-1's Week 48 data, already disclosed in June, head to AIDS 2026 on July 29 as Merck and Gilead push once-weekly oral dosing against daily standards of care.

Veradermics' oral VDPHL01 posts hair-count gains in small open-label female trial

Wed, 15 Jul 2026 11:00:00 GMT

A 49-patient, uncontrolled Phase 2 readout showed hair-count increases and high patient-reported improvement rates, with the harder registration-directed Study 306 due in 1H 2027.

Keytruda monotherapy beats chemo on PFS in dMMR endometrial cancer

Wed, 15 Jul 2026 10:45:00 GMT

KEYNOTE-C93 hit its progression-free survival goal for pembrolizumab alone, but overall survival, the trial's other primary endpoint, remains immature.

GST-HG171 needs lower dosing in kidney disease as impairment raises drug exposure

Wed, 15 Jul 2026 10:23:00 GMT

A China-based renal-impairment study found GST-HG171 exposure rose with worsening kidney function, leading to modeling-based dose cuts for patients with impaired renal clearance.

J&J's apalutamide cuts metastasis or death risk in PROTEUS prostate cancer trial

Wed, 15 Jul 2026 10:20:00 GMT

The Phase 3 PROTEUS trial met both co-primary endpoints, with perioperative apalutamide lowering metastasis-free survival risk by 20% ahead of the trial's December 2026 completion date.

Nipocalimab hit its SLE endpoint in 2026; J&J's Q2 release restates it without new data

Wed, 15 Jul 2026 10:20:00 GMT

The Phase 2 JASMINE trial met its SRI-4 primary endpoint earlier this year; J&J's July 15 earnings release recaps the finding but adds no new numbers as Phase 3 GARDENIA continues enrolling.

Assay validates lumateperone PK profile in Chinese subjects for the first time

Wed, 15 Jul 2026 08:13:00 GMT

An LC-MS/MS method quantifying lumateperone and its four active metabolites reported the drug's first full pharmacokinetic profile in a Chinese population.

Stapokibart post-hoc analysis links eosinophil drop to EASI-75 gains in atopic dermatitis

Wed, 15 Jul 2026 07:53:00 GMT

A pooled analysis of phase II and phase III trials shows stapokibart lowered blood eosinophil counts and paired that drop with higher EASI-75 response, regardless of baseline eosinophil level.

Early ivarmacitinib response at week 4 predicted better week-16 outcomes

Wed, 15 Jul 2026 07:23:00 GMT

A post hoc analysis of a phase 3 atopic dermatitis trial found early EASI 75 responders sustained higher skin-clearance and quality-of-life gains through week 52 than late or non-responders.

Preoperative acupoint stimulation cuts post-mastectomy pain in sleep-disturbed patients

Wed, 15 Jul 2026 04:54:00 GMT

A 59-patient trial links preoperative TEAS to lower pain scores and better sleep after breast cancer surgery, with reduced intraoperative blood pressure swings as a possible mechanism.

First-in-human data show XT1061 tolerable in healthy volunteers

Wed, 15 Jul 2026 04:49:00 GMT

A Phase Ia study of the hepatitis B capsid assembly modulator XT1061 found dose-proportional exposure and no difference in adverse events versus placebo, clearing the way for patient trials.

Escitalopram edges vortioxetine on depression symptom relief at 4 weeks

Wed, 15 Jul 2026 04:45:00 GMT

A 100-patient randomized trial found escitalopram produced lower HAM-D depression scores than vortioxetine at week 4, a difference reaching statistical significance.

Post-op dexmedetomidine nasal spray improves sleep, not anxiety, after laparoscopy

Wed, 15 Jul 2026 01:23:00 GMT

A randomized trial found a second nighttime dose of dexmedetomidine nasal spray preserved sleep architecture and shortened hospital stay, but did not separate from control on next-day insomnia scores.

Jenscare's LuX-Valve Plus tricuspid trial passes completion date with no results posted

Wed, 15 Jul 2026 00:00:00 GMT

The 126-patient pivotal device trial reached its March 2026 primary completion date, but the composite clinical success and safety data have not appeared on the registry.

Pfizer posts Phase 2 window-of-opportunity data for atirmociclib in breast cancer

Wed, 15 Jul 2026 00:00:00 GMT

The 121-patient study measured Ki-67 cell-cycle arrest at Day 14, a short pharmacodynamic readout, feeding a CDK4/6 franchise where atirmociclib already won FOURLIGHT-1 on progression-free survival.

Salubris completes Phase 3 sacubitril/allisartan trial in Chinese hypertension

Wed, 15 Jul 2026 00:00:00 GMT

The 376-patient trial finished on schedule against a blood-pressure endpoint, testing whether Salubris's triple-drug combination beats amlodipine alone in patients uncontrolled on amlodipine.

Salubris completes Phase 3 add-on trial of its sacubitril/allisartan hypertension pill

Wed, 15 Jul 2026 00:00:00 GMT

The 346-patient China trial finished with a blood-pressure endpoint on the books, but no result has posted yet on a therapy already sold as a fixed-dose combination.

Sumgen pulls in SG1827 Phase 1 completion date to March 2026, then March passes

Wed, 15 Jul 2026 00:00:00 GMT

Hangzhou Sumgen Biotech's dose-finding trial for SG1827 has moved its primary completion date three times, most recently to a date already in the past, with no posted safety or dose data.

Kelun-Biotech's sac-TMT plus Keytruda hits PFS goal in PD-L1-negative NSCLC

Tue, 14 Jul 2026 23:30:00 GMT

OptiTROP-Lung06's interim analysis is the first Phase 3 ADC-immunotherapy combination to clear its primary endpoint in driver-negative, PD-L1-negative NSCLC, a segment where checkpoint inhibitors alone underperform.

Veradermics to unveil Phase 2 female-arm data for oral minoxidil pill VDPHL01

Tue, 14 Jul 2026 23:05:29 GMT

The July 15 readout tests whether an extended-release oral minoxidil tablet can grow hair in women, feeding a Phase 3 program already running in men.

FDA approves Celcuity's REVTORPYK, first pan-PI3K/mTOR drug, in HR+/HER2- breast cancer

Tue, 14 Jul 2026 20:53:30 GMT

The approval rests on VIKTORIA-1 data showing gedatolisib cut progression risk 76% with palbociclib and 67% without it, versus fulvestrant alone.

Annexon's ARCHER data will pick who enrolls in pivotal ARCHER II readout

Tue, 14 Jul 2026 20:25:31 GMT

A Phase 2 baseline-characteristics analysis of vonaprument in geographic atrophy sets up the enrollment logic behind Annexon's 659-patient Phase 3 trial, due to read out in the fourth quarter of 2026.

Annexon frames Phase 2 vonaprument vision data as blueprint for pivotal Phase 3

Tue, 14 Jul 2026 20:05:00 GMT

ARCHER hit vision-preservation measures and photoreceptor protection, but the press release omitted the trial's own registered endpoint, GA lesion growth rate, ahead of Phase 3 ARCHER II data due in Q4 2026.

Alpha Tau to present full HNSCC data after 75% ORR interim readout

Tue, 14 Jul 2026 18:48:26 GMT

The AHNS podium talk on July 21 will report complete results from a 48-patient Israeli study pairing Alpha DaRT radiation seeds with pembrolizumab in elderly head and neck cancer, building on an 8-patient interim look that showed a 75% objective response rate.

Alkeus to present Phase 2 TEASE gildeuretinol data alongside Phase 3 design at ASRS

Tue, 14 Jul 2026 18:46:24 GMT

The July 18 presentation covers a Phase 2 tolerability study built around a safety endpoint, with Alkeus using the session to preview the Phase 3 NORTHSTAR design that will test disease-modifying efficacy.

Axsome's ENGAGE trial tests solriamfetol in binge eating disorder past a stale completion date

Tue, 14 Jul 2026 18:46:16 GMT

Axsome guides to H2 2026 topline data for solriamfetol in binge eating disorder even as the registry still lists the trial recruiting against a December 2025 completion date.

Enterome's EO2463 vaccine posts 74% ORR in lymphoma combination cohort

Tue, 14 Jul 2026 18:46:12 GMT

Updated SIDNEY data due at the Pan Pacific Lymphoma Conference will test whether an off-the-shelf peptide vaccine can hold its interim response and durability numbers as more patients mature.

Eupraxia's EP-104GI heads toward Phase 2b EoE readout after early biopsy signal

Tue, 14 Jul 2026 17:07:25 GMT

The Q4 2026 RESOLVE data will test whether injected fluticasone propionate holds up in a placebo-controlled cohort after open-label EREFS gains at 20 injections.

AIM's DURIPANC trial nears enrollment finish, primary readout due December

Tue, 14 Jul 2026 17:06:16 GMT

The Ampligen-durvalumab pancreatic cancer study plans to close enrollment in July 2026, setting up a December clinical benefit rate readout with no direct precedent in the field.

MediciNova heads toward summer topline data for tipelukast in diabetic NAFLD

Tue, 14 Jul 2026 17:06:10 GMT

The Phase 2 trial closed enrollment at its 40-patient target, leaving co-primary liver-fat and triglyceride results as the next test for a mechanism with no direct precedent.

Curis sets up TakeAim CLL dosing by July, data due December 2026

Tue, 14 Jul 2026 17:05:57 GMT

The Phase 2 combination trial pairs emavusertib with zanubrutinib in patients whose CLL persists despite the BTK inhibitor, testing whether adding an IRAK4/FLT3 blocker can deepen response.

Celldex's prurigo nodularis data for barzolvolimab lands with itch-relief bar set at Week 12

Tue, 14 Jul 2026 17:04:30 GMT

The Phase 2 trial completed enrollment at target and stands active but not recruiting, setting up a placebo-controlled readout on worst-itch relief with no direct KIT-targeted precedent in this disease.

Kodiak's DAYBREAK trial nears wet AMD readout against Aflibercept

Tue, 14 Jul 2026 17:03:00 GMT

Enrollment is complete and the primary completion date has passed; topline data testing whether Zenkuda and KSI-501 match Aflibercept on vision gain are expected in September 2026.

Karyopharm's XPO1 maintenance trial in endometrial cancer nears its PFS readout

Tue, 14 Jul 2026 17:02:09 GMT

XPORT-EC-042 is the only Phase 3 test of an XPO1 inhibitor in TP53 wild-type endometrial cancer, placing selinexor's maintenance benefit against placebo with no in-class precedent to benchmark against.

Pharming widens leniolisib beyond APDS to broader PI3Kδ-driven PIDs in H2 2026 test

Tue, 14 Jul 2026 17:01:59 GMT

A 12-patient Phase 2 trial extends Pharming's approved PI3Kδ inhibitor to genetically defined immunodeficiencies with safety, not efficacy, as the registered primary endpoint.

Connect Biopharma's rademikibart faces asthma test after enrollment closes

Tue, 14 Jul 2026 17:01:18 GMT

Seabreeze STAT completed enrollment at its 160-patient target, and Connect Biopharma now heads toward a September topline readout testing whether rademikibart cuts treatment failure after an acute asthma flare.

Acumen's sabirnetug Alzheimer's readout nears with amyloid class 3-for-3 in Phase 3

Tue, 14 Jul 2026 17:01:16 GMT

ALTITUDE-AD tests whether an amyloid oligomer-selective antibody can clear the iADRS bar that lecanemab and donanemab have already met, with topline data due within Acumen's 2026 window.

BioVie's bezisterim faces first Phase 2 test as monotherapy in untreated Parkinson's

Tue, 14 Jul 2026 17:01:08 GMT

SUNRISE-PD is the only trial testing an ERK1/2 and NF-κB inhibitor in Parkinson's, with topline data due after a five-month primary completion date slip.

NeOnc's NEO100 heads toward an interim readout in a glioma trial with no direct rival

Tue, 14 Jul 2026 17:00:11 GMT

NeOnc Technologies expects an interim look at its fully enrolled Phase 2a NEO100 study in recurrent IDH1-mutant high-grade glioma sometime in the second half of 2026, seven years after the trial's original completion target.

Invivyd's pivotal COVID prevention trial pushes readout into Q3 2026

Tue, 14 Jul 2026 16:59:08 GMT

A sample-size increase in the BLA-directed DECLARATION trial added roughly 500 subjects and pushed Invivyd's topline guidance from mid-2026 to Q3, the only Phase 3 test of an antibody built to prevent COVID-19 before exposure.

MediciNova heads toward H2-2026 ALSFRS-R data for ibudilast in ALS

Tue, 14 Jul 2026 16:58:46 GMT

The COMBAT-ALS trial is the only Phase 2/3 PDE4-inhibitor program running in ALS, leaving a functional-decline and survival readout with no direct in-class comparator.

Incyte's povorcitinib asthma readout slips again as Phase 2 nears finish

Tue, 14 Jul 2026 16:58:19 GMT

The JAK1 inhibitor's proof-of-concept trial has pushed its primary completion date five times, and Incyte still points to an H2-2026 data window for a lung-function endpoint no placebo-controlled JAK1 asthma trial has yet delivered.

Nektar's rezpeg faces Q4 off-treatment readout after alopecia data already showed responses

Tue, 14 Jul 2026 16:58:17 GMT

REZOLVE-AA's 24-week off-treatment data will test whether rezpegaldesleukin's alopecia areata responses persist after dosing stops, following positive on-treatment results already disclosed.

Nektar to present 36-week rezpegaldesleukin maintenance data in H2 2026

Tue, 14 Jul 2026 16:53:33 GMT

REZOLVE-AD's Week 16 primary readout already showed EASI reduction versus placebo; the pending presentation extends that signal through 36 weeks as Nektar moves the drug into Phase 3.

Vera pulls forward ORIGIN 3 kidney-function readout for atacicept to Q3 2026

Tue, 14 Jul 2026 16:52:06 GMT

The FDA-aligned eGFR analysis will test whether atacicept's proteinuria benefit in IgA nephropathy extends to slowing kidney function decline, the data full approval will rest on.

Celcuity's gedatolisib faces July 17 FDA decision on 16.6-month PFS data

Tue, 14 Jul 2026 16:51:58 GMT

The PDUFA date tests whether a 14.7-month progression-free survival gain over fulvestrant alone converts to approval under Priority Review and Real-Time Oncology Review.

Altimmune's pemvidutide faces Q3 alcohol-disorder readout after enrollment closed early

Tue, 14 Jul 2026 16:49:44 GMT

The RECLAIM Phase 2 trial completed enrollment ahead of schedule, and its heavy-drinking-days endpoint will test pemvidutide beyond the obesity and MASH programs that anchor Altimmune's pipeline.

Travere's HARMONY trial for HCU pushes primary completion 20 months to 2027

Tue, 14 Jul 2026 16:49:29 GMT

The Phase 3 readout the company once flagged for 2026 now depends on a trial that shifted its own completion target and returned to active recruiting.

REGENXBIO to present 2.5-year ALTITUDE gene therapy data as NAAVIGATE enrolls

Tue, 14 Jul 2026 16:48:02 GMT

The July ASRS presentation extends two-year dose-level-3 data already tied to no intraocular inflammation, as AbbVie's larger Phase IIb/III NAAVIGATE trial tests the same suprachoroidal dose in a sham-controlled design.

FDA tells Longeveron its HLHS trial's endpoint can't prove efficacy, mid-study

Tue, 14 Jul 2026 16:44:11 GMT

The agency rejected ejection fraction as sufficient in ELPIS II and stripped the study of pivotal status, leaving Longeveron to defend a new composite endpoint once August's blinded data unblind.

Cloudbreak's CBT-001 nears Phase 3 pterygium data after Phase 2 hit both endpoints

Tue, 14 Jul 2026 16:43:38 GMT

The topical multi-kinase inhibitor reduced pterygium vascularity and lesion size versus vehicle in Phase 2, setting the bar its 660-patient Phase 3 must replicate in a disease with no approved disease-modifying drug.

Ocugen to detail OCU410 gene therapy imaging and safety data at ASRS

Tue, 14 Jul 2026 16:42:45 GMT

The July 17 presentation extends Ocugen's preliminary ArMaDa readout with imaging and safety detail, testing whether the 31% lesion-growth reduction holds up in a subretinal gene therapy field with no approved disease-modifying option.

AtaiBeckley's DMT film for resistant depression heads to a Q4 readout

Tue, 14 Jul 2026 16:41:53 GMT

Elumina finished dosing at 156 patients, setting up a placebo-controlled MADRS test that will decide whether VLS-01 moves into a broader depression program.

Ollin presents head-to-head OLN324 vs. Vabysmo data at ASRS ahead of Phase 3

Tue, 14 Jul 2026 16:41:27 GMT

The Phase 1b JADE readout, already disclosed in March, gets an oral presentation on anatomic and vision outcomes as Ollin heads toward Phase 3 trials in DME and wet AMD.

Cognition's zervimesine slowed DLB hallucinations 89%, FDA calls it approvable

Tue, 14 Jul 2026 16:37:33 GMT

New Phase 2 SHIMMER data due at AAIC in July extend a placebo-controlled result that already secured FDA alignment on a Phase 3 psychosis trial for a disease with no approved therapy.

Eisai brings AHEAD 3-45 retention data to AAIC, not efficacy results

Tue, 14 Jul 2026 16:37:13 GMT

The Phase 3 prevention trial in preclinical Alzheimer's will show participant retention and engagement data at AAIC in July, with the amyloid-PET primary endpoint still years from readout.

REGENXBIO to present five-year RGX-314 wet AMD gene therapy data in July

Tue, 14 Jul 2026 16:36:40 GMT

The ASRS presentation extends a durability record already tied to reduced anti-VEGF injections, arriving as AbbVie's subretinal pivotal trials near a Q4 2026 readout.

Codex Labs to present 95% SCORAD drop in open-label pediatric eczema pilot

Tue, 14 Jul 2026 16:35:07 GMT

The Silicon Valley skincare company will show an 80-child, single-arm result at a pediatric dermatology meeting, a descriptive signal rather than a controlled comparison against standard eczema care.

Viatris awaits July 30 FDA decision on low-dose estrogen contraceptive patch

Tue, 14 Jul 2026 16:31:22 GMT

The 505(b)(2) filing rests on a completed Phase 3 trial that already reported a 4.14 Pearl Index, leaving the label and any FDA follow-up requests as the open questions.

Moderna's mRNA-1010 flu shot heads to FDA on a 26.6% efficacy edge over standard vaccines

Tue, 14 Jul 2026 16:29:56 GMT

The August 5 PDUFA date tests whether a Phase 3 win against licensed flu vaccines in adults 50 and older, published in NEJM, converts into the first mRNA seasonal flu approval.

Nocion's Phase 2b cough trial nears data after two completion-date pushes

Tue, 14 Jul 2026 16:29:00 GMT

ASPIRE's placebo-controlled readout will test whether taplucainium cuts cough frequency, the first efficacy signal for Nocion's sensory-neuron blocker class in this indication.

Nervonik to present nerve-sensing data from 8-patient study at ASPN 2026

Tue, 14 Jul 2026 16:24:18 GMT

The device recorded electrical nerve signals during peripheral nerve stimulation in a small feasibility study, a step toward closed-loop pain therapy still years from a registrational trial.

MapLight's ZEPHYR schizophrenia trial completes, results due by mid-August

Tue, 14 Jul 2026 16:24:08 GMT

The Phase 2 test of ML-007C-MA finished enrollment at 307 patients and closed out on schedule, setting up a PANSS readout against placebo within weeks.

Acumen's AAIC poster is patient survey data, not ALTITUDE-AD topline results

Tue, 14 Jul 2026 16:17:12 GMT

The July 14 presentation covers patient perspectives from the trial population, while the actual iADRS readout for sabirnetug is not due until the trial's October 2026 primary completion.

Organon to show pooled ADORING data on VTAMA in AD across pediatric, adult ages

Tue, 14 Jul 2026 16:16:40 GMT

The July 22 presentation recasts already-approved Phase 3 results by age subgroup rather than adding a new clinical readout for the AhR agonist cream.

CervoMed posts first 80 mg neflamapimod data in Lewy body dementia

Tue, 14 Jul 2026 16:16:33 GMT

The Phase 2 dose-finding trial met its safety and pharmacokinetic goals, and CervoMed says the result sets the dose for a planned Phase 3 program in a disease with no approved treatment.

NewAmsterdam extends obicetrapib's LDL story into an Alzheimer's biomarker signal

Tue, 14 Jul 2026 16:16:24 GMT

A poster at AAIC 2026 builds on a prespecified BROADWAY biomarker analysis that already showed a p-tau217 reduction at 12 months, positioning the LDL-lowering drug for a disease it was never designed to treat.

Belite Bio's DRAGON data head to ASRS as first Phase 3 win in Stargardt disease

Tue, 14 Jul 2026 16:16:23 GMT

Tinlarebant already cut Stargardt lesion growth 35.7% versus placebo in the completed DRAGON trial; the ASRS presentation puts that result before retina specialists for the first time.

NewAmsterdam extends obicetrapib's cardiovascular data into an Alzheimer's biomarker signal

Tue, 14 Jul 2026 16:16:19 GMT

Posters at AAIC 2026 build on BROADWAY's prespecified p-tau217 finding, testing whether a CETP inhibitor built for cholesterol has a case in Alzheimer's prevention.

Alzheon presses ALZ-801 case with 4-year data after Phase 3 miss

Tue, 14 Jul 2026 16:14:29 GMT

The AAIC posters lean on long-term extension biomarkers and imaging from a completed Phase 2 trial to reframe an oral amyloid drug whose placebo-controlled Phase 3 did not hit its primary endpoint.

Cognition Therapeutics to detail Phase 3 plan for CT1812 in DLB psychosis

Tue, 14 Jul 2026 16:14:03 GMT

The July 16 fireside chat centers on a registrational Lewy body dementia psychosis study built on Phase 2 SHIMMER data, not new results from the ongoing Alzheimer's trial.

Nocion to detail ASPIRE cough trial status as Q3 readout nears

Tue, 14 Jul 2026 16:10:50 GMT

A July 16 poster update on taplucainium precedes topline data from the placebo-controlled Phase 2b trial, the first U.S. cough therapy readout to test a charged sodium channel blocker.

Alkeus to detail Phase 3 gildeuretinol design for Stargardt disease at ASRS

Tue, 14 Jul 2026 16:10:38 GMT

The presentation pairs Phase 2 TEASE safety and efficacy data with the design of the enrolling Phase 3 NORTHSTAR trial, the study that will test whether gildeuretinol slows lesion growth against placebo.

Mighty Therapeutics details FDA-mandated Phase 4 trial confirming elamipretide in Barth syndrome

Tue, 14 Jul 2026 16:07:43 GMT

The July 22 conference presentation covers a 48-patient confirmatory trial required after FORZINITY's accelerated approval, not a new efficacy readout.

Astellas to present GATHER1 driving-eligibility and EZ integrity data for IZERVAY at ASRS

Tue, 14 Jul 2026 16:07:32 GMT

New biomarker and functional analyses from the completed GATHER1 trial extend evidence behind the only approved complement inhibitor for geographic atrophy.

Astellas to unveil first Phase 1b look at stem cell therapy ASP7317 in GA

Tue, 14 Jul 2026 16:06:49 GMT

The July 15 ASRS presentation offers the first preliminary human data on early visual improvement and safety signals for a stem cell-derived retinal implant in geographic atrophy.

Ollin details OLN324's head-to-head edge over faricimab in wAMD at ASRS

Tue, 14 Jul 2026 16:06:46 GMT

The Phase 1b JADE data Ollin previewed in March get their full airing at ASRS, setting up global Phase 3 trials in wet AMD and diabetic macular edema later this year.

Biogen to unveil first CELIA data on tau-targeting BIIB080 at AAIC

Tue, 14 Jul 2026 16:06:39 GMT

The Phase 2 CELIA study tests whether reducing tau production with an antisense drug moves CDR-SB in early Alzheimer's, a mechanism with no approved precedent.

Ocugen to detail 1-year OCU410 gene therapy data for geographic atrophy at ASRS

Tue, 14 Jul 2026 16:05:31 GMT

The presentation follows a 31% reduction in lesion growth reported at 12 months, and the ASRS talk will show whether that effect and safety hold at one year.

AstraZeneca expands ARTEMIDE-Lung02 to 1,160 patients, extends completion to 2030

Tue, 14 Jul 2026 15:39:20 GMT

The Phase 3 trial testing rilvegostomig against pembrolizumab in squamous NSCLC grew its enrollment target 32% and pushed its primary completion date more than a year, changes that widen the eventual overall-survival readout rather than signal trouble.

AstraZeneca expands Rilvegostomig lung cancer trial to 1,160 patients

Tue, 14 Jul 2026 15:39:19 GMT

The Phase 3 head-to-head against pembrolizumab now targets 1,160 first-line NSCLC patients, up from 878, as its completion date moves to November 2030.

Akeso registers Phase 3 test of cadonilimab against nivolumab in gastric cancer

Tue, 14 Jul 2026 15:38:11 GMT

The 900-patient trial pits Akeso's PD-1/CTLA-4 bispecific against a chemo-plus-nivolumab arm, a head-to-head bar cadonilimab has not faced in this setting.

CSPC Megalith opens Phase 2 test of therapeutic HPV vaccine for cervical lesions

Tue, 14 Jul 2026 15:34:58 GMT

SYS6026 aims to clear HPV16/18 infection and reverse high-grade cervical lesions without surgery, in a trial that will read out by September 2028.

Gubra registers first-in-human trial for obesity peptide GUB-UCN2

Tue, 14 Jul 2026 15:26:52 GMT

The three-part Phase 1/2 study will test safety and pharmacokinetics of the urocortin-2 analog in lean, obese and type 2 diabetes cohorts ahead of a December 2028 completion.

Vigonvita opens enrollment in Phase 1 food-effect study of VV913 capsules

Tue, 14 Jul 2026 15:25:44 GMT

The Chinese trial will test how a meal changes VV913 absorption in healthy volunteers, a routine step before the drug can move into dosing studies that matter more.

Boehringer completes enrollment in nerandomilast-pirfenidone interaction study

Tue, 14 Jul 2026 15:25:15 GMT

The Phase 2 pharmacokinetic study, now closed to enrollment, will test whether pirfenidone changes blood levels of nerandomilast, the PDE4B inhibitor Boehringer sells as JASCAYD for IPF.

Nexcella's NXC-201 trial stops enrolling after a 95% response rate in AL amyloidosis

Tue, 14 Jul 2026 15:25:07 GMT

NEXICART-2 closed enrollment at 45 patients months after Immix reported a 19-of-20 complete response rate, setting up a December primary completion in a disease with no approved cell therapy.

Vigonvita opens dosing in early Phase 1 study of oral VV913 in China

Tue, 14 Jul 2026 15:25:01 GMT

The multiple-ascending-dose trial in healthy male volunteers now needs to show a clean safety and pharmacokinetic profile through year-end to support any move into patients.

Hengrui tests autoinjector for SHR-1703 in a bridging pharmacokinetics study

Tue, 14 Jul 2026 15:24:58 GMT

The Phase 1 trial compares a pre-filled syringe and an autoinjector for SHR-1703, a device-format study rather than a new efficacy readout.

Multitude Therapeutics opens dosing in AMT-116 lung cancer combination with Ivonescimab

Tue, 14 Jul 2026 15:19:37 GMT

The Phase 1/2 trial pairs an unproven bispecific with the PD-1 x VEGF-A drug now advancing across dozens of NSCLC studies, with tolerability and response data due by mid-2027.

Kelun-Biotech to test B7-H3 ADC plus PD-1 blocker in esophageal cancer

Tue, 14 Jul 2026 15:16:05 GMT

The Phase 2 combination trial adds a sixth industry program to a B7-H3 field in esophageal squamous cell carcinoma with no completed or terminated precedent yet.

GSK tests depemokimab alone, without steroids, for nasal polyps in Japan

Tue, 14 Jul 2026 15:15:53 GMT

A Phase 4 trial will ask whether depemokimab holds up as monotherapy without intranasal steroids, a stricter bar than the placebo-controlled wins that backed its approval.

Innovent opens dosing in Phase 1 trial of TED antibody IBI3031

Tue, 14 Jul 2026 15:15:24 GMT

The China-based safety study enrolls patients with active thyroid eye disease as Innovent adds an eighth mechanism to a field already anchored by teprotumumab and three late-stage rivals.

AstraZeneca closes enrollment in Phase 2 test of eplontersen plus ALXN2220 combo

Tue, 14 Jul 2026 15:15:18 GMT

The 326-patient ATTRiumph trial will test whether adding an anti-amyloid antibody to eplontersen clears cardiac amyloid faster than the approved RNA drug alone, with results due in 2029.

Peg-Bio starts Phase 1 dose-escalation trial of PA5 in advanced tumors

Tue, 14 Jul 2026 15:15:00 GMT

The China-based trial will test safety and find a recommended dose for a tumor-agnostic asset whose target and mechanism remain unspecified in the registry.

Akeso starts dosing AK146D1-AK112 combination in advanced NSCLC

Tue, 14 Jul 2026 15:09:16 GMT

The Phase 2 trial pairs Akeso's ADC with its approved bispecific ivonescimab, testing a combination in a lung cancer field already dense with PD-1-directed programs.

ImmunoBrain's anti-PD-L1 antibody clears safety bar in early Alzheimer's

Tue, 14 Jul 2026 14:00:00 GMT

Phase 1b data published in Nature Medicine show IBC-Ab002 was well tolerated in 40 patients, with CSF biomarker reductions concentrated in the highest-dose group.

SPR to present 12-month RESET trial results for SPRINT PNS in back pain

Tue, 14 Jul 2026 13:24:58 GMT

The randomized RESET trial tested 60-day peripheral nerve stimulation against usual care in chronic low back pain, with 12-month outcomes reaching a public podium for the first time.

Cebranopadol clears Phase 3 pain trial, Adneuris licenses China rights

Tue, 14 Jul 2026 12:30:00 GMT

ALLEVIATE-1 hit its pain-reduction endpoint against placebo after abdominoplasty, and Adneuris paired the readout with a Greater China license as it prepares an FDA filing.

HUYABIO's HBI-8000 combo nearly doubles PFS versus nivolumab alone in melanoma

Tue, 14 Jul 2026 12:00:00 GMT

The Phase 3 HBI-8000-303 trial hit its primary endpoint at 11.7 versus 7.4 months median PFS, giving the HDAC inhibitor a shot at frontline melanoma where it faces no direct HDAC-class rival.

Trispecific CD19/20/22 CAR T shows 50% response rate in first-in-human trial

Tue, 14 Jul 2026 11:54:00 GMT

Sixteen patients with relapsed or refractory B-cell malignancies received the point-of-care manufactured trispecific CAR T, designed to blunt single-antigen escape that drives relapse after CD19-only CAR T.

CervoMed's 80mg neflamapimod hits safety goal in small open-label DLB study

Tue, 14 Jul 2026 11:30:00 GMT

The 26-patient Phase 2 trial met its safety and pharmacokinetic objectives, but the company's own Phase 2b trial had already failed to replicate earlier cognitive benefit data in this same drug program.

Kura to show longer follow-up on darlifarnib-cabozantinib in kidney cancer

Tue, 14 Jul 2026 11:15:50 GMT

The July 24 presentation extends Phase 1a data already showing a 44% response rate in pretreated patients, this time in cabozantinib-naive advanced clear cell RCC.

Ivonescimab plus chemo shows early activity in two recurrent H3K27M glioma cases

Tue, 14 Jul 2026 11:15:00 GMT

A two-patient pilot report finds partial tumor shrinkage and tolerability with an anti-PD-1/VEGF bispecific in a cancer with a typical median survival under a year.

Tiragolumab-atezolizumab combo raises rash and infusion-reaction risk, meta-analysis finds

Tue, 14 Jul 2026 10:32:00 GMT

A pooled analysis of five randomized trials in 1,001 patients links dual TIGIT/PD-L1 blockade to more skin and infusion toxicity without a rise in severe adverse events.

Warming blankets cut shivering in hypothermic elderly surgery patients

Tue, 14 Jul 2026 10:27:00 GMT

A two-phase Chinese study links traditional-medicine constitution, low BMI, and low pre-op temperature to intraoperative hypothermia, and finds active warming lowered postoperative shivering rates.

AI-designed antibody GB-0669 neutralizes SARS-CoV-2 in first human trial

Tue, 14 Jul 2026 10:02:00 GMT

A first-in-human study of an AI-optimized antibody targeting a conserved spike region showed dose-dependent virus neutralization and no dose-limiting toxicity in 51 healthy adults.

PD-1-enhanced HIV DNA vaccine ICVAX shows tolerability, T-cell response in Phase 1

Tue, 14 Jul 2026 10:02:00 GMT

A 45-patient placebo-controlled trial found ICVAX safe in ART-treated HIV-1 patients and more likely than placebo to raise antigen-specific T-cell responses, with viral-reservoir effects left for future study.

Neoadjuvant nedaplatin-paclitaxel yields 30.3% pCR in esophageal cancer trial

Tue, 14 Jul 2026 08:04:00 GMT

A single-arm phase II trial found lymph-node status and tumor FOXP3/TIGIT expression tracked survival after chemoradiotherapy in esophageal squamous cell carcinoma.

Ciprofol clears slower and sedates deeper in elderly patients, PK/PD study finds

Tue, 14 Jul 2026 06:54:00 GMT

A 40-patient comparative study finds age-related drops in ciprofol clearance drive higher exposure and more adverse events, while sedation depth on key measures stayed equivalent.

Third-generation EGFR-TKIs tie each other on PFS in network meta-analysis

Tue, 14 Jul 2026 06:46:00 GMT

A pooled analysis of 11 randomized trials and 4,663 patients finds osimertinib, furmonertinib and six other third-generation EGFR-TKIs all beat first-generation drugs, but not each other, on progression-free survival.

Meta-analysis ties PD-(L)1 benefit in gastric cancer to metastasis site, histology

Tue, 14 Jul 2026 06:45:00 GMT

Pooling six phase 3 trials and 5,410 patients, the analysis finds checkpoint inhibitors add little survival benefit when peritoneal metastases or diffuse-type histology are present.

Ascendis posts ApproaCH Phase 3 growth data behind already-approved Yuviwel

Tue, 14 Jul 2026 00:00:00 GMT

Posted results show navepegritide beat placebo on growth velocity in children 5 and older, a subgroup result that lands after the drug's FDA approval and priority review.

Bausch & Lomb completes Phase 2 test of lifitegrast-perfluorohexyloctane combo for dry eye

Tue, 14 Jul 2026 00:00:00 GMT

The 443-patient trial finished on schedule with results not yet posted, leaving open whether pairing two established dry-eye mechanisms beats either alone.

Createrna's QR12000 completes Phase 2 hypertension trial, results not yet posted

Tue, 14 Jul 2026 00:00:00 GMT

The 391-patient trial closed in September 2023 with a blood-pressure primary endpoint, but ClinicalTrials.gov carries no posted result data on the readout.

Fujian Shengdi completes Phase 3 test of GLP-1 drug HRS9531 in diabetes

Tue, 14 Jul 2026 00:00:00 GMT

The placebo-controlled trial finished on schedule with no posted HbA1c data yet, leaving the readout that will show whether HRS9531 matches China's crowded incretin field still ahead.

FDA approves once-weekly subcutaneous LEQEMBI IQLIK for early Alzheimer's

Mon, 13 Jul 2026 21:36:00 GMT

The approval lets patients start lecanemab with a 15-second weekly injection instead of an IV infusion, backed by exposure data showing the shot matches IV dosing.

Ascentage's pelcitoclax pairs with osimertinib but stalls in resistant NSCLC

Mon, 13 Jul 2026 21:02:00 GMT

A phase 1b trial found the BCL-2/BCL-xL inhibitor drove an 80.8% response rate in TKI-naive patients but only 10.7% after resistance had already set in.

Oral bofanglutide shows sub-2% bioavailability but clean safety in Phase 1

Mon, 13 Jul 2026 19:11:00 GMT

A Chinese healthy-volunteer study found the SNAC-formulated oral GLP-1 well tolerated with only grade 1 GI side effects, though absorption stayed under 1.5% across doses.

Elevar's lirafugratinib faces Sept. 27 FDA decision on 46.5% ORR in bile duct cancer

Mon, 13 Jul 2026 18:55:52 GMT

Priority review for the FGFR2 inhibitor rests on a single-arm response rate in FGFR2 fusion-positive cholangiocarcinoma, with no other FGFR2-targeted drug in Phase 3 for this population.

Nuvalent's zidesamtinib nears Sept. 18 FDA decision on breakthrough-tagged ROS1 NSCLC drug

Mon, 13 Jul 2026 18:55:43 GMT

The pending decision covers TKI pre-treated ROS1-positive NSCLC, a setting where zidesamtinib holds breakthrough and orphan designations and the feeding trial itself remains open and recruiting.

Mirum's zilurgisertib nears Sept. 26 FDA verdict as first ALK2 drug for FOP

Mon, 13 Jul 2026 18:55:33 GMT

The FDA's priority review of Incyte's ALK2 inhibitor, licensed to Mirum, would deliver the first approved drug for the connective-tissue disease, with no direct comparator yet through review.

FDA priority review sets Aug. 27 decision on Gilead's BIC/LEN switch pill

Mon, 13 Jul 2026 18:55:26 GMT

The once-daily combination must show it holds virologic suppression as well as complex regimens it aims to replace, after Phase 3 data already backed the filing.

Agios awaits FDA filing verdict on mitapivat after mixed RISE UP results

Mon, 13 Jul 2026 18:55:21 GMT

The sNDA rests on a hemoglobin-response win but a missed pain-crisis co-primary, testing whether accelerated approval and a confirmatory trial can carry the drug in sickle cell disease.

Etripamil awaits NMPA verdict in China after already winning FDA nod

Mon, 13 Jul 2026 18:55:13 GMT

Corxel's nasal-spray PSVT drug seeks approval in China by the third quarter of 2026, a market with 3 to 6 million patients, building on its December 2025 FDA clearance.

Praxis faces Sept. 27 FDA decision on relutrigine while its own trial still enrolls

Mon, 13 Jul 2026 18:55:03 GMT

The PDUFA date for relutrigine in SCN2A/SCN8A epilepsy lands two months before the Phase 3 EMERALD trial's own primary completion date, leaving the confirmatory readout to trail the regulatory decision.

Eupraxia's EP-104GI faces H2 2026 test after early EoE injections showed 65% EREFS gains

Mon, 13 Jul 2026 18:55:02 GMT

The placebo-controlled Phase 2b RESOLVE readout will show whether injected fluticasone propionate can convert open-label esophageal improvements into a controlled result in eosinophilic esophagitis.

NeOnc's NEO100 nears 2026 glioma data after nine-year, six-slip delay

Mon, 13 Jul 2026 18:55:00 GMT

NeOnc's intranasal perillyl alcohol trial in recurrent IDH1-mutant glioma has no direct comparator in development, and its primary completion date has moved six times since 2020.

BMS's Camzyos hits Week 28 goal in teens, sets up Sept. 30 FDA call

Mon, 13 Jul 2026 18:54:56 GMT

SCOUT-HCM cut Valsalva LVOT gradient by 48.0 mm Hg versus placebo, and the FDA will decide by September 30 whether that extends Camzyos to adolescents with obstructive HCM.

Inventiva's NATiV3 completion date slips 43 months, pushing lanifibranor readout to late 2027

Mon, 13 Jul 2026 18:51:49 GMT

The Phase 3 MASH trial's primary completion date has moved four times since 2023, and the warrant financing tied to topline data now outlives the trial's own registered timeline.

Inhibrx's DR5 antibody ozekibart heads to FDA review after halving progression risk

Mon, 13 Jul 2026 18:51:38 GMT

The ChonDRAgon trial met its primary endpoint with a 52% reduction in progression or death versus placebo, setting up an April 2027 FDA decision in a cancer with no approved systemic therapy.

Coya's ALSTARS trial to test whether Treg biologic slows ALS decline

Mon, 13 Jul 2026 18:51:12 GMT

The randomized, placebo-controlled Phase 2 trial is still enrolling toward a Q1 2027 readout window, with no direct precedent yet for a Treg-targeting combination in ALS.

Apnimed's AD109 heads to FDA review after 55.6% AHI drop in sleep apnea trial

Mon, 13 Jul 2026 18:50:59 GMT

The SynAIRgy trial's primary endpoint is already public: AD109 cut apnea events by more than half versus placebo, setting the stage for a Q1 2027 FDA decision on the first oral drug for obstructive sleep apnea.

Nxera's daridorexant hits sTST goal in South Korea Phase 3, eyes 2027 nod

Mon, 13 Jul 2026 18:50:54 GMT

The Phase 3 trial met all primary and secondary endpoints on subjective sleep time, positioning an MAA filing and a Q1 2027 approval target for an already-approved insomnia drug.

Everest Medicines takes China rights to LENZ's approved presbyopia drop VIZZ

Mon, 13 Jul 2026 18:50:42 GMT

NMPA approval of aceclidine drop LNZ100 in China is anticipated in Q1 2027, resting on the same Phase 3 program that already won U.S. approval, not a new efficacy bar.

Lexicon's SONATA-HCM heads to Q1 2027 with no HCM drug yet SGLT-class approved

Mon, 13 Jul 2026 18:50:39 GMT

Sotagliflozin, already approved for heart failure, is being tested as the first SGLT1/SGLT2 inhibitor in hypertrophic cardiomyopathy, with topline data due in Q1 2027.

Savara's inhaled GM-CSF nears an EU verdict backed by a positive Phase 3 DLCO result

Mon, 13 Jul 2026 18:50:28 GMT

MOLBREEVI's CHMP decision is expected in Q1 2027, arriving after IMPALA-2 already reported a lung-function benefit over placebo, with FDA and MHRA reviews running in parallel.

Amplexd sets Q1 2027 readout for EGCg suppository in HPV cervical lesions

Mon, 13 Jul 2026 18:50:27 GMT

The randomized, placebo-controlled Phase 2 trial will test whether a self-administered topical can clear high-risk HPV and reverse mild cytologic abnormalities now managed by watchful waiting.

CervoMed sets up nfvPPA data test for neflamapimod as DLB partnering takes priority

Mon, 13 Jul 2026 18:49:34 GMT

A 20-patient Phase 2a safety and biomarker study in a rare aphasia becomes the next readout while CervoMed pursues a partner for its larger dementia with Lewy bodies program.

Quince's inhaled sirolimus faces a lonely BOS test as Q1 2027 data near

Mon, 13 Jul 2026 18:49:20 GMT

The Phase 2 trial of LAM-001 in bronchiolitis obliterans syndrome has no direct comparator, and the sponsor's own guided readout window has already slipped once before this one opens.

Arcutis-linked roflumilast foam faces a 10-patient HS test with no active comparator

Mon, 13 Jul 2026 18:49:10 GMT

A Tulane-run Phase 2 proof-of-concept trial of ZORYVE foam 0.3% in hidradenitis suppurativa will read out a gene-expression endpoint in a field with no other PDE4 program past Phase 2.

Calluna's AURORA trial for CAL101 in IPF nears Q1 2027 lung-function data

Mon, 13 Jul 2026 18:49:00 GMT

The Phase 2 study finished enrollment early and moved its completion date up nine months, setting up a first efficacy test for an S100A4-targeted antibody in fibrotic lung disease.

Veru sets Q1 2027 interim look at enobosarm's bid to beat GLP-1 weight-loss plateau

Mon, 13 Jul 2026 18:48:54 GMT

The Phase 2b PLATEAU trial will test whether enobosarm preserves lean mass and extends weight loss beyond semaglutide alone, building on a positive earlier study in the same combination.

FDA to decide on zipalertinib for EGFR exon 20 NSCLC by Feb. 27, 2027

Mon, 13 Jul 2026 18:48:54 GMT

The NDA rests on a 35% response rate in 176 pretreated patients from the REZILIENT1 trial, in a field where no exon-20-targeted therapy has yet cleared amivantamab-based regimens as the benchmark to beat.

Gilead's weekly oral lenacapavir PrEP pill faces FDA decision Feb. 2, 2027

Mon, 13 Jul 2026 18:48:33 GMT

The sNDA leans on injectable Yeztugo's already-established PURPOSE 1 and PURPOSE 2 efficacy data, so the decision turns on whether a daily pill matches that bar, not on new trial results.

Climb Bio's budoprutug already showed 90% B-cell depletion in ITP before H2 data

Mon, 13 Jul 2026 18:48:33 GMT

The Phase 1b/2a trial's initial cohort posted platelet gains at EHA in June, so the H2 2026 readout Climb Bio flagged will extend, not introduce, an efficacy signal.

Dyne's ACHIEVE trial for DM1 heads to a Q1 2027 readout after full enrollment

Mon, 13 Jul 2026 18:48:11 GMT

Enrollment at 116 is unchanged, but the primary completion date moved from 2026 to 2029, even as Dyne says the registrational readout stays on track for Q1 2027.

Astria's navenibart Phase 3 in HAE heads toward a 2026 readout

Mon, 13 Jul 2026 18:48:04 GMT

ALPHA-ORBIT will test whether navenibart's early attack-reduction data hold up placebo-controlled in the only Phase 3 plasma kallikrein program in hereditary angioedema.

Pacira's ZILRETTA shoulder OA trial nears readout after enrollment closed

Mon, 13 Jul 2026 18:47:58 GMT

The Phase 3 study finished enrollment in April 2026 and could make ZILRETTA the first approved treatment specifically labeled for shoulder osteoarthritis pain.

Cabaletta's rese-cel gMG data due in H2 2026, months after AAN preview

Mon, 13 Jul 2026 18:47:57 GMT

The RESET-MG trial's complete Phase 1/2 dataset is coming after a partial April 2026 presentation showed clinical responses in most evaluable patients, setting up whether the full cohort holds up.

Insmed's open-label TPIP extension in PAH tests durability, not a new efficacy bar

Mon, 13 Jul 2026 18:47:05 GMT

The Phase 2/3 extension study reports safety and functional data in the second half of 2026, extending an already-reported Phase 2b signal in pulmonary arterial hypertension.

Cartesian's Descartes-08 heads to Phase 3 MG readout as only such trial in class

Mon, 13 Jul 2026 18:46:27 GMT

The AURORA trial is the sole Phase 3 program pairing a BCMA-directed CAR-T with myasthenia gravis, leaving no direct precedent for what its MG-ADL result should look like.

Aktis targets Q1 2027 dose-finding readout for Nectin-4 radioconjugate AKY-1189

Mon, 13 Jul 2026 18:46:09 GMT

Fast Track-designated AKY-1189 will report Part 1 safety and dose-limiting toxicity data as the only Phase 1 Nectin-4 radioconjugate in a field otherwise led by antibody-drug conjugates.

Immunocore heads toward H2 2026 dose data on second PRAME bispecific

Mon, 13 Jul 2026 18:45:58 GMT

IMC-P115C's Phase 1 safety and tolerability readout, expected in the second half of 2026, will test whether Immunocore's half-life-extended PRAME candidate can extend a franchise built on brenetafusp.

Immunocore's second PRAME cell therapy heads to a safety readout in H2 2026

Mon, 13 Jul 2026 18:45:56 GMT

IMC-P115C, a half-life-extended PRAME binder, is a dose-escalation trial testing tolerability, not efficacy, and it follows the company's more advanced PRAME asset brenetafusp.

DBV plans BLA for peanut patch in toddlers as safety trial keeps enrolling

Mon, 13 Jul 2026 18:44:23 GMT

DBV Technologies is preparing an accelerated-approval submission for Viaskin Peanut in 1-to-3-year-olds while the supporting safety study continues recruiting toward its own November 2026 completion.

ImPact's Padeliporfin hits 70% complete-response rate ahead of planned 2026 NDA

Mon, 13 Jul 2026 18:44:21 GMT

ENLIGHTED trial data show a 70% complete-response rate with 24-month durability in low-grade UTUC, as ImPact still targets an NDA submission this year.

DBV's Viaskin peanut patch safety study in toddlers nears its readout

Mon, 13 Jul 2026 18:44:16 GMT

COMFORT Toddlers will report adverse-event and serious-adverse-event data in a randomized, placebo-controlled safety design, feeding directly into DBV's planned BLA for 1-to-3-year-olds.

Beacon's laru-zova gene therapy nears pivotal XLRP readout

Mon, 13 Jul 2026 18:43:39 GMT

The VISTA trial's 12-month topline data, expected in the second half of 2026, will be the first pivotal test of a subretinal gene therapy for RS1-linked XLRP.

Rhythm's setmelanotide awaits Japan verdict after US and EU nods in hypothalamic obesity

Mon, 13 Jul 2026 18:43:26 GMT

Japan's PMDA is reviewing setmelanotide for acquired hypothalamic obesity after the same pivotal trial cleared the FDA and European Commission this year, with a decision expected in the second half of 2026.

Arrowhead's ARO-MAPT tau data due H2 2026 in a field with no approved tau drug

Mon, 13 Jul 2026 18:43:03 GMT

The Phase 1/2a trial testing Arrowhead's RNAi tau-silencer in early Alzheimer's is designed for safety and PK first, with efficacy signals still to come.

CG Oncology's cretostimogene combo hits 96% early bladder cancer control

Mon, 13 Jul 2026 18:42:44 GMT

CORE-008 Cohort CX paired cretostimogene with gemcitabine in high-risk bladder cancer, and CG Oncology now owes the field durability data to show the early signal holds.

Immatics' Phase 3 melanoma cell therapy trial heads toward 2026 readout

Mon, 13 Jul 2026 18:42:42 GMT

SUPRAME is the only Phase 3 trial testing a PRAME-targeted cell therapy in previously treated cutaneous melanoma, with a pre-specified analysis due in 2026 while the trial still recruits toward 360 patients.

Acadia's ACP-204 psychosis trial still recruiting as guided readout window opens

Mon, 13 Jul 2026 18:42:38 GMT

The registered completion date for Acadia's Alzheimer's psychosis study runs to 2028, well past the sponsor's own mid-2026 readout guidance, raising a timing gap the company has not reconciled.

BioCardia targets Japan PMDA filing for CardiAMP after years of trial delay

Mon, 13 Jul 2026 18:42:35 GMT

The Phase 3 CardiAMP heart failure trial finished in 2025 after five completion-date pushes and a target cut in half; the Japan submission will test whether that record supports a regulatory case.

MaaT013 awaits EMA verdict after 62% GI response rate in ARES trial

Mon, 13 Jul 2026 18:41:25 GMT

The EMA is weighing approval of MaaT Pharma's fecal microbiome therapy for gut GvHD after it failed on no arm to compare against, in patients other treatments had already failed.

Compass sets up full COMPANION-002 data unveil after tovecimig hit ORR, PFS

Mon, 13 Jul 2026 18:41:23 GMT

Compass Therapeutics will present the complete COMPANION-002 dataset, including duration of response, later in 2026, building on an already-disclosed 17.1% response rate and a 56% reduction in progression risk for tovecimig in second-line biliary tract cancer.

Relmada readies Phase 3 NDV-01 bladder cancer trial after 95% Phase 2 CR rate

Mon, 13 Jul 2026 18:40:59 GMT

RESCUE has not yet started recruiting, but the initial 3-month readout Relmada guided to by year-end 2026 will be the first Phase 3 test of a Phase 2 complete-response signal that topped 94% in BCG-unresponsive patients.

SeaStar's NEUTRALIZE-AKI trial grows to 339 patients, pushes readout to 2026

Mon, 13 Jul 2026 18:40:42 GMT

SeaStar Medical raised its pivotal AKI trial's enrollment target 70% and pushed the completion date a year, testing whether its cytopheretic device beats CRRT alone on a 90-day mortality composite.

Dynavax's Z-1018 heads into head-to-head shingles data versus Shingrix

Mon, 13 Jul 2026 18:40:34 GMT

Part 1 showed immune responses comparable to Shingrix with favorable tolerability; Part 2 in adults 70 and older will test non-inferiority against the market leader.

Ionis targets a 2026 launch for zilganersen, its first neurology drug filing

Mon, 13 Jul 2026 18:40:16 GMT

The Phase 3 trial behind the Alexander disease therapy finished enrollment at 54 patients after a target cut from 73, with Ionis still guiding to an NDA filing and launch this year.

Evommune's oral EVO756 heads to a Phase 2b eczema readout in H2 2026

Mon, 13 Jul 2026 18:40:03 GMT

The 120-patient trial tests whether blocking MRGPRX2, a target with no approved drug in atopic dermatitis, can move EASI scores against placebo.

Kodiak's KSI-101 heads to Phase 3 readout after Phase 1b BCVA and drying data

Mon, 13 Jul 2026 18:40:00 GMT

PEAK trial data due by early 2027 must replicate the vision gains and rapid retinal drying KSI-101 showed in a 39-patient Phase 1b study, in a disease with no approved treatment.

Ocular Therapeutix plans AXPAXLI wet AMD NDA on SOL-1 data, not SOL-R efficacy

Mon, 13 Jul 2026 18:39:33 GMT

The Q4 2026 filing drops SOL-R's own year-one efficacy data from the package, leaning on SOL-1 results while SOL-R shifts to test superiority over high-dose aflibercept at Week 96.

Perspective's VMT01 melanoma readout will test early signal of 2 of 7 responses

Mon, 13 Jul 2026 18:37:44 GMT

Perspective Therapeutics has already disclosed two confirmed responses among seven monotherapy patients in its MC1R-targeted radiopharmaceutical trial, ahead of a mid-to-late 2026 update.

Spyre's SPY072 basket trial heads toward three-indication readout in Q4 2026

Mon, 13 Jul 2026 18:37:36 GMT

SKYWAY will test the anti-TL1A antibody head-on against DAS-CRP, ACR20 and ASDAS bars across RA, PsA and axial spondyloarthritis with no direct same-target rival yet in human data.

Immatics readies IMA402 dose and Phase 1 data for melanoma, ovarian tumors

Mon, 13 Jul 2026 18:35:05 GMT

The PRAME-targeting bispecific's second-half update will set the recommended Phase 2 dose and post monotherapy and checkpoint-combination data in an indication with no approved bispecific of its kind.

PolyPid's D-PLEX100 heads to FDA review with a PDUFA date near Q1 2027

Mon, 13 Jul 2026 18:34:55 GMT

The NDA rests on a completed 800-patient trial, Breakthrough Therapy and Fast Track status, and no approved drug yet prevents surgical site infection this way.

Cerus's ReCePI trial met its AKI non-inferiority bar ahead of 2026 FDA filing

Mon, 13 Jul 2026 18:34:52 GMT

Cerus already showed INTERCEPT RBCs match conventional red cells on kidney injury risk; the open question is whether the RedeS trial's safety data holds before the H2 2026 PMA module goes in.

Vivani's semaglutide implant faces its first human PK test by year-end

Mon, 13 Jul 2026 18:34:25 GMT

SLIM-1 will compare a subdermal semaglutide implant against injected semaglutide in 20 obesity patients, testing whether the delivery format works before any Phase 2 dosing decision.

Cerus nears FDA filing for RedeS red-cell trial after 692-patient enrollment closes

Mon, 13 Jul 2026 18:34:24 GMT

The Phase 3 RedeS trial finished enrollment at 692 patients and is set to complete in mid-2026, positioning Cerus for the final PMA module it has guided toward since 2023.

Cerus's RedeS Phase 3 nears results after enrollment closed on schedule

Mon, 13 Jul 2026 18:34:15 GMT

The pathogen-reduction trial that took nine years to fill its 692-patient target now heads toward a second-half 2026 readout that will decide the PMA path for INTERCEPT RBCs.

Ocugen's OCU400 Phase 3 in retinitis pigmentosa nears topline data, enrollment closed

Mon, 13 Jul 2026 18:33:52 GMT

The only Phase 3 gene therapy trial testing a gene-agnostic mechanism across broad RP mutations has finished enrolling, setting up a 12-month functional-vision readout expected in Q1 2027.

Alnylam's ALN-HTT02 heads to H2 2026 safety readout in Huntington's

Mon, 13 Jul 2026 18:32:48 GMT

The Phase 1 trial tests tolerability of a huntingtin-lowering RNAi drug, with mHTT knockdown in spinal fluid as the biology to watch alongside adverse events.

Iovance's NSCLC filing hinges on IOV-LUN-202 data still to come in 2026

Mon, 13 Jul 2026 18:32:34 GMT

Fast Track status for lifileucel in lung cancer puts a regulatory filing on the calendar, but the feeder trial's own completion date sits four years out.

Kelun-Biotech readies first human data for its ITGB6-targeted ADC SKB105

Mon, 13 Jul 2026 18:32:19 GMT

The Phase 1/2 dose-escalation trial of CR-003 (SKB105), an integrin beta-6-directed antibody-drug conjugate, targets proof-of-concept data in Q1 2027, with no direct clinical precedent for the mechanism.

Alpha Tau widens pancreatic cancer trial to test alpha radiation with more chemo regimens

Mon, 13 Jul 2026 18:32:07 GMT

Alpha Tau expanded the IMPACT trial's chemotherapy backbone and raised enrollment to 40 as it targets initial safety results by year-end 2026.

Immix's NXC-201 posts 95% CR rate in AL amyloidosis ahead of March 2027 update

Mon, 13 Jul 2026 18:31:52 GMT

Nineteen of 20 evaluable patients reached complete response in the CAR-T trial, setting up 1-year follow-up data Immix says will support a BLA filing.

BioRestorative completes BRTX-100 enrollment, sets up 2027 spine trial readout

Mon, 13 Jul 2026 18:30:19 GMT

The sham-controlled Phase 2 trial in chronic lumbar disc disease finished enrolling 99 patients, with topline results expected in early 2027 and no validated cell therapy yet approved for the indication.

Immatics' SUPRAME trial advances toward 2026 enrollment completion in melanoma

Mon, 13 Jul 2026 18:29:37 GMT

The only Phase 3 program targeting PRAME in checkpoint-refractory melanoma is recruiting toward a 2026 enrollment finish, setting up a progression-free survival readout against investigator's-choice therapy.

NextCure pushes LNCB74 -tumor data to H2 2026 as enrollment lags

Mon, 13 Jul 2026 18:29:17 GMT

The B7-H4 antibody-drug conjugate's dose-escalation trial is still recruiting, so the proof-of-concept signal investors want now folds into a later progress update.

Transgene's TG4050 heads toward first Phase II immune data in H2 2026

Mon, 13 Jul 2026 18:27:25 GMT

The readout will test whether the individualized cancer vaccine's Phase I immune responses and disease-free survival extend into the randomized Phase II population.

Barinthus Bio's celiac vaccine faces H2 2026 safety readout for AVALON

Mon, 13 Jul 2026 18:25:32 GMT

The Phase 1 AVALON trial tests whether VTP-1000's multiple-dose safety and antibody data hold up after single-dose results and a pending Clywedog merger reset expectations.

Zealand's ZP9830 SAD data clear safety bar; MAD readout due H2 2026

Mon, 13 Jul 2026 18:24:52 GMT

Single doses of the Kv1.3 blocker showed no dose-limiting toxicity and dose-dependent target engagement, setting up multiple-dose safety data as the next test for Zealand Pharma's chronic-inflammation entry.

Tenaya to present two-year TN-201 gene therapy data in HCM in H2 2026

Mon, 13 Jul 2026 18:24:40 GMT

MyPEAK-1's planned late-2026 update will extend safety and MyBP-C biomarker signals already reported from a 7-patient dose-finding cohort in a trial with no direct clinical competitor.

BioLineRx's GLIX1 dose-escalation trial in glioma advances toward first human data

Mon, 13 Jul 2026 18:23:26 GMT

The oral TET2 activator has no direct precedent in high-grade glioma, so the first-in-human safety and dose-finding results will be the earliest test of whether the mechanism translates from mice to patients.

Kodiak's Phase 3 PINNACLE for KSI-101 targets BCVA gains in Q1 2027

Mon, 13 Jul 2026 18:15:41 GMT

The sham-controlled study will test whether an IL-6/VEGF bispecific can beat sham on vision gains in inflammatory macular edema, a mechanism with no resolved Phase 3 precedent in this population.

Tectonic's TX45 heads to Q1 2027 readout after full enrollment in PH-HFpEF

Mon, 13 Jul 2026 18:14:54 GMT

The Phase 2 APEX trial enrolled 191 patients with topline data due by March 2027, testing whether an Fc-relaxin fusion protein can move pulmonary vascular resistance in a disease with no approved therapy.

Alnylam's RNAi obesity drug ALN-2232 heads toward first human weight-loss data

Mon, 13 Jul 2026 18:12:35 GMT

A Phase 1/2 trial testing whether silencing ACVR1C can cut body weight is recruiting toward a primary completion date in April 2027, well past the H2-2026 window Alnylam has flagged for initial results.

Zai Lab's DLL3 ADC zoci nears first combo readout in frontline SCLC

Mon, 13 Jul 2026 18:11:45 GMT

A dose-escalation and expansion trial testing zoci with atezolizumab, with and without chemotherapy, in untreated small-cell lung cancer is set to post data in the second half of 2026.

BioAtla's BA3182 tests durability as expansion-phase data near in H2 2026

Mon, 13 Jul 2026 18:11:40 GMT

The bispecific already showed a confirmed partial response past six months and manageable cytokine release; the expansion readout will test whether that holds across more patients.

Agomab's ontunisertib extension data due H2 2026 will test durability in Crohn's

Mon, 13 Jul 2026 18:11:28 GMT

The open-label extension of the STENOVA trial will show whether ontunisertib's Part A benefit in fibrostenosing Crohn's holds through 48 weeks, with no approved disease-modifying comparator to beat.

Cenna's 8M2D targets amyloid production, not clearance, in first human test

Mon, 13 Jul 2026 18:11:19 GMT

A Phase 1 trial set to start dosing in late 2026 will test whether blocking beta-amyloid production, rather than clearing plaque after it forms, is safe in people.

Plus Therapeutics eyes Q1 2027 data for radiopharmaceutical in recurrent glioma

Mon, 13 Jul 2026 18:11:15 GMT

REYOBIQ's ReSPECT-GBM trial still lists Recruiting status and a 2025 completion date, well ahead of the company's guided Q1 2027 readout window.

Therini Bio's THN391 heads toward first human data in DME this quarter

Mon, 13 Jul 2026 18:10:15 GMT

The Phase 1b trial targets fibrin's inflammatory epitope instead of VEGF, an approach with no direct clinical precedent, and initial safety and biomarker data are due in the fourth quarter.

PepGen's low-dose DM1 cohort missed on function; next dose is the test

Mon, 13 Jul 2026 18:10:09 GMT

The 5 mg/kg cohort of PepGen's FREEDOM2 trial showed no improvement in handgrip or walking speed, putting weight on the 10 mg/kg readout due in the second half of 2026.

Adagio's vCLAS posts 59% VT-free rate at 6 months ahead of PMA decision

Mon, 13 Jul 2026 18:09:49 GMT

FULCRUM-VT's single-arm pivotal data show 84% freedom from ICD shock and a 2.4% adverse-event rate, setting the bar for the FDA's expected 2026 marketing decision.

Adicet's prula-cel faces systemic sclerosis test in a Phase 1 safety cohort

Mon, 13 Jul 2026 18:09:12 GMT

Adicet Bio plans a systemic sclerosis update on prula-cel by year-end, a safety and dose-finding readout in a trial with no direct competitor sharing its gamma delta CAR-T mechanism.

Biogen to detail salanersen Phase 1b data as Phase 3 program advances behind it

Mon, 13 Jul 2026 18:08:57 GMT

Salanersen already showed 75% NfL reductions and new motor milestones in gene-therapy-experienced children, and Biogen just won Breakthrough Therapy Designation on that basis.

Fractyl's Revita device faces pivotal weight-maintenance test this Q4

Mon, 13 Jul 2026 18:08:47 GMT

REMAIN-1's sham-controlled data will show whether duodenal ablation can hold weight loss after patients stop tirzepatide, a gap no drug or device has yet closed.

Edwards awaits FDA call on PASCAL for tricuspid regurgitation as pivotal trial keeps enrolling

Mon, 13 Jul 2026 18:08:46 GMT

Edwards expects a Q4 2026 FDA decision on PASCAL for tricuspid regurgitation, but the pivotal CLASP II TR trial's own completion date runs to December 2027, after a 46% enrollment target increase.

IceCure asks Health Canada to widen ProSense cryoablation to older women

Mon, 13 Jul 2026 18:08:08 GMT

A Health Canada decision expected in H2 2026 would extend the FDA-cleared cryoablation device to a broader population, three years after FDA denied the same claim on the same trial data.

Oragenics eyes Q4 2026 readout for ONP-002 in mTBI, a trial not yet enrolling

Mon, 13 Jul 2026 18:07:58 GMT

The Phase 2a placebo-controlled study of Oragenics' intranasal ONP-002 targets a Q4 2026 final readout even though the 40-patient trial in Australia has not started recruiting.

Vanda's second Phase 3 test of milsaperidone in depression targets Q1 2027

Mon, 13 Jul 2026 18:05:34 GMT

Already approved for bipolar I and schizophrenia, milsaperidone now faces a randomized, placebo-controlled trial testing whether it works as an add-on antidepressant in a crowded MDD field.

Oral mesoglycan beats placebo on symptom score in acute hemorrhoidal disease trial

Mon, 13 Jul 2026 18:05:00 GMT

A 52-patient randomized trial found mesoglycan cut the Hemorrhoidal Disease Symptom Score more than placebo over 40 days, with benefits concentrated in grade III disease.

Dianthus keeps Q4 2026 target for DNTH103 trial in rare nerve disease

Mon, 13 Jul 2026 18:04:03 GMT

The Phase 2 MoMeNtum trial pits claseprubart against placebo in multifocal motor neuropathy, a setting with no approved complement-targeted therapy and where IVIg remains the standard of care.

60 Gy dose escalation fails to beat 50 Gy in esophageal cancer at 8 years

Mon, 13 Jul 2026 18:04:00 GMT

A phase 3 trial's long-term follow-up confirms escalated radiation adds no survival benefit, while spatial tumor profiling points to why some patients still fail standard-dose chemoradiotherapy.

Aclaris heads toward H2 2026 Phase 2 readout for TSLP drug bosakitug in eczema

Mon, 13 Jul 2026 18:03:58 GMT

The trial has finished enrolling and completed dosing, setting up a placebo-controlled EASI readout that will test whether bosakitug can compete with dupilumab-class biologics in moderate-to-severe eczema.

Dianthus clears CIDP interim GO gate; Part B relapse data due by year-end

Mon, 13 Jul 2026 18:03:15 GMT

The Phase 3 CAPTIVATE trial hit its Part A responder bar with 20 confirmed responders, and Dianthus now moves to the randomized-withdrawal Part B, the study that will decide the drug's regulatory path in CIDP.

Terumo readies Japan filing for IceCure's breast-cancer cryoablation device

Mon, 13 Jul 2026 18:03:04 GMT

The PMDA submission leans on ICE3 trial data and follows the FDA's 2023 De Novo denial for the same device in the same indication in the U.S.

BioVersys plans BV100 interim readout as its Phase 3 program runs in parallel

Mon, 13 Jul 2026 18:02:23 GMT

The open-label RIV-CARE Phase 2b trial in drug-resistant Acinetobacter infections has not yet started enrolling, testing the timeline for a Q4 2026 safety and efficacy interim look.

Atisama's inhaled RB042 heads toward higher-dose Phase 1 safety readouts

Mon, 13 Jul 2026 18:02:08 GMT

Three of four single-dose cohorts cleared safety and tolerability, positioning multi-dose data due later in 2026 to test whether the inhaled RAGE-targeted oligonucleotide holds up at higher exposure.

Agomab awaits first IPF patient data on inhaled AGMB-447 in late 2026

Mon, 13 Jul 2026 18:01:52 GMT

The Phase 1 trial completed in April 2026 with safety and tolerability as its primary measures, setting up the first IPF patient results for an inhaled, lung-restricted TGF-beta blocker.

60 Degrees reports all three babesiosis patients cured with tafenoquine regimen

Mon, 13 Jul 2026 18:01:28 GMT

An expanded-access study designed to confirm Yale's reported cure rate for tafenoquine in relapsing babesiosis reported 3 of 3 patients cured, as the sponsor pursues a Breakthrough Therapy request and an NDA path built on this and two other trials.

AdipoPharma's PATAS heads toward first human safety data by year-end

Mon, 13 Jul 2026 18:00:36 GMT

The Phase 1 trial testing a fat-cell-targeted insulin sensitizer has finished dosing single ascending doses, setting up initial safety data that will show whether the mechanism clears its first human bar.

Akebia's AKB-9090 begins dosing in Phase 1 trial testing kidney-injury biomarkers

Mon, 13 Jul 2026 18:00:21 GMT

The randomized, placebo-controlled study in healthy volunteers will read out safety and pharmacodynamic biomarker data by the end of 2026, the first human evidence for a candidate Akebia is developing to prevent kidney injury after cardiac surgery.

4DMT's 4D-150 heads toward 2-year DME data after 86% injection cut at 32 weeks

Mon, 13 Jul 2026 18:00:07 GMT

SPECTRA's interim results already showed 4D-150 cut aflibercept injections 86% versus projected need; the H2 2026 2-year data will test whether that durability holds.

Aligos targets 2026 for first interim data on HBV pill ALG-000184

Mon, 13 Jul 2026 18:00:00 GMT

The oral capsid assembly modulator had all 11 HBeAg-negative Phase 1 subjects reach sustained viral suppression through 96 weeks; a 200-subject randomized trial against tenofovir is next.

Health Canada approves Novartis's Vanrafia for IgA nephropathy proteinuria

Mon, 13 Jul 2026 18:00:00 GMT

The approval rests on the same Week 36 interim UPCR reduction that already won US accelerated approval, with the ALIGN trial's eGFR-based final analysis still to come.

NovaBridge's ragistomig posts Q6W safety edge ahead of H2 2026 Phase 1 readout

Mon, 13 Jul 2026 17:58:55 GMT

A December 2025 dose-expansion update showed lower liver toxicity on a less frequent dosing schedule, setting up further data from the same Phase 1 trial by year-end 2026.

Dogwood's Halneuron heads toward Phase 2b pain data with no direct rival

Mon, 13 Jul 2026 17:58:15 GMT

The randomized, placebo-controlled trial testing Halneuron in chemotherapy nerve pain is still recruiting toward a mid-2026 completion, with final 200-patient data expected in the second half of the year.

MetaVia's DA-1726 heads toward Q4 data testing higher-dose tolerability

Mon, 13 Jul 2026 17:58:07 GMT

The Phase 1 titration studies test whether MetaVia's oxyntomodulin analog tolerates 48 mg and 64 mg doses as well as it did 32 mg, the profile the company says rivals its earlier weight-loss signal.

Alnylam's ALN-6400 heads toward first human safety data in HHT this year

Mon, 13 Jul 2026 17:57:33 GMT

A Phase 1/2 trial testing Alnylam's plasminogen-targeting RNAi drug in hereditary hemorrhagic telangiectasia is set to post healthy-volunteer safety data after a 20-month completion-date slip.

AtaiBeckley eyes Q4 data from BPL-003's two-dose TRD cohort as Phase 3 launches

Mon, 13 Jul 2026 17:57:09 GMT

The open-label Phase 2a readout comes as AtaiBeckley runs a separate, larger placebo-controlled Phase 3 program testing the same drug in treatment-resistant depression.

XVIVO to file heart-preservation device for FDA approval after PRESERVE trial hit

Mon, 13 Jul 2026 17:57:06 GMT

XVIVO plans a PMA submission in the second half of 2026 built on PRESERVE Trial results showing 92.1% treatment success at Day 30 and 91.4% survival at Day 365 in extended-criteria donor hearts.

Rigel targets H2 2026 Phase 2 dose pick for R289 after 33% RBC-TI signal

Mon, 13 Jul 2026 17:56:58 GMT

Rigel plans to select a recommended Phase 2 dose for its IRAK1/4 inhibitor R289 in lower-risk MDS by year-end, building on a small dose-expansion cohort that showed transfusion independence in one third of evaluable patients.

Monte Rosa's MRT-8102 faces H2 test to confirm 85% CRP cut in more patients

Mon, 13 Jul 2026 17:56:16 GMT

GFORCE-1's expanded cohort will show whether the oral NEK7 degrader's interim CRP reduction holds as Monte Rosa readies a Phase 2 ASCVD study.

Zai Lab's ZL-1503 heads to H2 2026 safety readout in atopic dermatitis

Mon, 13 Jul 2026 17:56:11 GMT

The Phase 1/1b trial will report first-in-human safety and tolerability data that Zai Lab says will set up Phase 2 testing in atopic dermatitis patients.

Cybin's CYB003 heads to Q4 2026 MDD readout after guiding six times

Mon, 13 Jul 2026 17:56:06 GMT

The Phase 3 APPROACH trial still targets a Q4 2026 topline readout after Cybin repeated that window through six disclosures, even as the registry's own completion date points to August.

Krystal's inhaled gene therapy for CF heads toward a 2026 Phase 1 readout

Mon, 13 Jul 2026 17:56:03 GMT

KB407, an inhaled herpesvirus-vector gene therapy for cystic fibrosis, targets a year-end 2026 readout after enrollment rose to 20 and the completion date slipped three years from its original mark.

Imbria's ninerafaxstat heads toward FORTITUDE-HCM data with no rival on its mechanism

Mon, 13 Jul 2026 17:55:58 GMT

The Phase 2b trial testing ninerafaxstat against placebo in non-obstructive HCM has no direct mechanistic comparator, leaving prior Phase 2a signals as the only benchmark for late-2026 topline data.

Glycomine's GLM101 nears first placebo-controlled test in PMM2-CDG

Mon, 13 Jul 2026 17:55:44 GMT

The Phase 2b/3 POLAR trial is the first randomized, placebo-controlled study of GLM101 in a disease with no approved therapy, with topline ataxia data due in Q4 2026.

Agios targets H2 2026 proof-of-mechanism readout for oral PKU drug AG-181

Mon, 13 Jul 2026 17:55:25 GMT

The Phase 1 trial testing whether AG-181 lowers phenylalanine in PKU patients runs a 2028 completion date, raising the question of what data a mid-trial readout can actually support.

CRISPR's FXI siRNA CTX611 heads toward H2 2026 data versus enoxaparin in TKA

Mon, 13 Jul 2026 17:55:25 GMT

A four-arm Phase 2 trial testing whether subcutaneous SRSD107 can cut VTE after knee replacement without a validated Factor XI precedent to lean on.

Alpha Tau's implanted-seed trial in recurrent GBM targets enrollment finish by H2 2026

Mon, 13 Jul 2026 17:55:24 GMT

The 10-patient feasibility study testing whether Alpha DaRT's radioactive seeds can be placed safely in recurrent glioblastoma is recruiting toward a stated second-half 2026 enrollment finish, with survival and safety data to follow.

Alpha Tau's GBM device trial heads to a small feasibility readout in Q4 2026

Mon, 13 Jul 2026 17:55:23 GMT

A 10-patient feasibility study of the Alpha DaRT radiation seed in recurrent glioblastoma is recruiting toward a safety and placement readout, not an efficacy verdict.

Bambusa's BBT002 heads toward a safety readout in COPD patients by year-end

Mon, 13 Jul 2026 17:54:57 GMT

The Phase 1 trial testing Bambusa's IL-4Ralpha/IL-5 bispecific in COPD patients is a safety and tolerability study, not an efficacy trial, with topline data expected by December 31, 2026.

Alto's ALTO-300 targets a biomarker-defined MDD subgroup in Phase 2b test

Mon, 13 Jul 2026 17:54:54 GMT

The adjunctive antidepressant's primary endpoint reads MADRS change in a pre-defined subgroup, not the full randomized population, setting a narrower bar than a standard depression trial.

NextCure's LNCB74 dose-escalation update tests a B7-H4 ADC facing GSK, AstraZeneca

Mon, 13 Jul 2026 17:54:40 GMT

NextCure plans a Phase 1 update on its B7-H4-targeted ADC LNCB74 in the second half of 2026, in a field where GSK and AstraZeneca already have Phase 3 B7-H4 ADCs running.

Azitra's ATR-04 rash trial pushes toward a first-cohort readout in H2 2026

Mon, 13 Jul 2026 17:54:29 GMT

The Phase 1/2 topical trial for EGFR inhibitor-associated rash is recruiting with placebo control, and its primary completion date has slipped twice, most recently by over 10 months.

Protara's THRIVE-3 heads toward H2 2026 readout with no rival IV choline trial

Mon, 13 Jul 2026 17:54:24 GMT

The Phase 2b/3 trial testing IV Choline Chloride against placebo is recruiting toward an interim analysis Protara has guided to since January, with no approved IV choline product and no competing trial in the same mechanism.

Nanjing Leads Biolabs sets up Phase 1 safety readout for dual-target lupus drug LBL-047

Mon, 13 Jul 2026 17:53:56 GMT

The first human data on a bifunctional BDCA2/BAFF-APRIL fusion protein will test tolerability, not efficacy, in healthy volunteers before the drug advances to lupus patients.

Disc Medicine's DISC-0974 heads to Q4 topline after ASCO data on 61 patients

Mon, 13 Jul 2026 17:53:11 GMT

RALLY-MF's transfusion-independence and hemoglobin-response readout will test whether early anemia gains in myelofibrosis hold up as the full Phase 2 cohort matures.

Avidity's del-brax BLA plan hinges on FORTITUDE biomarker data, not this OLE trial

Mon, 13 Jul 2026 17:53:02 GMT

The planned H2 2026 accelerated-approval filing for del-brax in FSHD rests on the FORTITUDE biomarker cohort readout, while the safety-focused extension study now runs to 2030.

Rigel targets 2026 R289 dose-expansion data after 33% transfusion independence

Mon, 13 Jul 2026 17:52:59 GMT

Rigel plans to report Phase 1b dose-expansion results for R289 in lower-risk MDS by year-end 2026, building on a 33% transfusion-independence rate seen in dose escalation.

Sionna's SION-451 combination trial heads to a safety readout this half

Mon, 13 Jul 2026 17:52:41 GMT

The Phase 1 healthy-volunteer study testing SION-451 alongside two other CFTR correctors is built to show whether the triple combination is tolerable, not whether it works in cystic fibrosis.

Apogee's safety trial of APG777+APG990 vs Dupixent nears H2 2026 readout

Mon, 13 Jul 2026 17:52:02 GMT

The fully enrolled Phase 1b study will report adverse-event rates against Dupixent, a tolerability test, not an efficacy verdict, for Apogee's atopic dermatitis combination.

Edwards' RESILIA tissue posts 97.9% freedom from valve deterioration at 10 years

Mon, 13 Jul 2026 17:51:57 GMT

The COMMENCE trial's decade-long follow-up gives Edwards Lifesciences durability data on its RESILIA-treated pericardial valves, a bar every next-generation tissue platform in aortic and mitral replacement will be measured against.

Septerna's oral PTH1R drug SEP-479 heads into Phase 1 readout for hypoparathyroidism

Mon, 13 Jul 2026 17:51:50 GMT

The healthy-volunteer safety trial will show whether an oral once-daily agonist can mimic PTH biology well enough to compete with Ascendis's injectable in a market it treats today.

NuCana's NUC-7738 melanoma data due in H2 2026 after early partial responses

Mon, 13 Jul 2026 17:51:20 GMT

NuCana plans final Phase 2 data on NUC-7738 plus pembrolizumab in PD-1-resistant melanoma later in 2026, building on two partial responses and one complete metabolic response shown so far.

Treace's ALIGN3D bunion study heads toward 5-year data in 2026

Mon, 13 Jul 2026 17:51:13 GMT

Four-year interim results already show recurrence under 8.4% and rapid return to weight-bearing, setting the bar the 5-year readout must hold.

60 Degrees eyes H2 2026 tafenoquine data as its babesiosis sNDA basis

Mon, 13 Jul 2026 17:51:12 GMT

A 40-patient chronic babesiosis trial and two sister studies are the evidence base for a planned tafenoquine filing, but the pivotal study's own completion date runs past the window.

Tectonic's TX45 heads to PH-HFpEF data test with no validated mechanism in the field

Mon, 13 Jul 2026 17:51:11 GMT

The APEX Phase 2 trial pits Tectonic's relaxin-receptor fusion protein against placebo in a heart-failure subtype where no therapy has yet shown a validated hemodynamic benefit.

Annexon's ARCHER II Sets Up Q4 Test of Vision Loss, Not Growth

Mon, 13 Jul 2026 17:51:02 GMT

The Phase 3 trial in geographic atrophy will report whether vonaprument slows BCVA loss, the first time visual preservation has anchored a pivotal readout in this disease.

Design Therapeutics builds on DT-216P2 frataxin gains ahead of H2 2026 update

Mon, 13 Jul 2026 17:50:04 GMT

The RESTORE-FA trial already showed dose-dependent frataxin increases and a 6.4-point mFARS improvement at four weeks; the pending update will test whether that holds through 12 weeks of dosing.

Vanda pushes Bysanti MDD trial readout to Q1 2027, a year past guidance

Mon, 13 Jul 2026 17:49:52 GMT

Vanda Pharmaceuticals now says its adjunctive-MDD Phase 3 for Bysanti (milsaperidone) will read out in Q1 2027, a year later than the 2026 window it gave three times before.

Alto's ALTO-100 bipolar depression trial tests a fix for its 2024 MDD miss

Mon, 13 Jul 2026 17:49:31 GMT

The Phase 2b readout, expected in H2 2026, is designed only as an adjunctive therapy after a compliance gap undercut the drug's prior depression trial.

Oruka's ORKA-001 hits 63.5% skin clearance; durability data due in H2

Mon, 13 Jul 2026 17:49:23 GMT

The IL-23p19 antibody cleared skin fully in 40 of 63 psoriasis patients at Week 16, and Oruka now must show that response holds through Week 52 with twice-yearly or less-frequent dosing.

Apogee's asthma antibody already showed FeNO cuts; more data due in H2

Mon, 13 Jul 2026 17:48:45 GMT

A 31-patient Phase 1b trial already reported interim FeNO suppression and a favorable safety readout; Apogee plans to add more zumilokibart asthma data at medical conferences by year end.

Lantern's LP-300 posts 8.3-month PFS signal in 16 EGFR L858R patients

Mon, 13 Jul 2026 17:48:18 GMT

HARMONIC's randomized OS/PFS readout is still pending in H2 2026, but Lantern has already disclosed a small, non-randomized subgroup result that will need to hold up as enrollment matures.

Satellos moves BASECAMP DMD readout timeline as trial keeps enrolling

Mon, 13 Jul 2026 17:47:58 GMT

Satellos pushed its Phase 2 BASECAMP completion date back a year to March 2027, yet still guides to Q4 2026 top-line data testing SAT-3247's muscle-strength effect in ambulatory boys with Duchenne.

Ultragenyx's pivotal Angelman syndrome trial nears its only readout window

Mon, 13 Jul 2026 17:47:13 GMT

The fully enrolled Phase 3 Aspire study of GTX-102 is the sole registrational trial testing the UBE3A pathway, with data due in H2 2026.

Disc Medicine's DISC-3405 heads to Q4 2026 PV data with no rival in human testing

Mon, 13 Jul 2026 17:45:51 GMT

The Phase 2 trial's primary endpoints are safety and tolerability, not a phlebotomy-response bar, and no other TMPRSS6 antibody has reached the clinic in polycythemia vera.

Moderna's mRESVIA revaccination data show durable immune response in adults 60+

Mon, 13 Jul 2026 17:45:45 GMT

Interim results from Moderna's Phase 3 booster study suggest a second mRESVIA dose restores RSV antibody levels comparable to the primary shot, with full data due later in 2026.

Biomea's Phase 1 oral GLP-1 BMF-650 nears first weight-loss data

Mon, 13 Jul 2026 17:45:12 GMT

A placebo-controlled dose-escalation study will produce Biomea's first 28-day weight data for BMF-650, testing an oral GLP-1 agonist against a field led by injectable incumbents.

Absci's ABS-201 posts clean SAD safety data ahead of H2 2026 efficacy readout

Mon, 13 Jul 2026 17:44:33 GMT

Interim Phase 1 data show the anti-PRLR antibody was well tolerated with a half-life above 65 days, setting up whether hair-regrowth data due by year-end back the mechanism in androgenetic alopecia.

Vertex's povetacicept BLA in IgA nephropathy carries a positive Week 36 result into FDA review

Mon, 13 Jul 2026 17:44:18 GMT

The RAINIER trial's interim data already showed a 49.8% placebo-adjusted UPCR reduction, so the November 30, 2026 decision now tests confirmatory durability, not first proof of concept.

Vertex targets H2 2026 for first VX-670 muscle-biopsy data in DM1

Mon, 13 Jul 2026 17:43:41 GMT

The GALILEO trial's multiple-ascending-dose cohort will report safety, tolerability, and a muscle splicing-index readout, the first clinical signal for Vertex's small-molecule bet on myotonic dystrophy type 1.

MoonLake to file HS drug on data with a missed Phase 3 endpoint

Mon, 13 Jul 2026 17:43:39 GMT

MoonLake plans a September 2026 BLA for sonelokimab in hidradenitis suppurativa built on two pivotal trials, one of which missed its primary endpoint at Week 16.

Kiniksa's KPL-387 heads toward first pericarditis data with no IL-1R1 rival

Mon, 13 Jul 2026 17:43:33 GMT

Kiniksa expects Phase 2 dose-finding data on its IL-1R1 antibody KPL-387 in recurrent pericarditis in the second half of 2026, testing a monthly at-home injection against Arcalyst's established biologic-suppression benchmark.

Zura Bio's dual BAFF/IL-17A antibody heads toward Phase 2 HS readout

Mon, 13 Jul 2026 17:43:21 GMT

TibuSHIELD will test whether hitting BAFF and IL-17A together beats placebo on lesion count in hidradenitis suppurativa, a field where single-target IL-17A drugs have already failed.

Alumis heads toward Q3 2026 LUMUS readout for oral TYK2 drug in lupus

Mon, 13 Jul 2026 17:43:16 GMT

The 408-patient Phase 2b trial will report whether ESK-001 beats placebo on BICLA response at Week 48, the first test of Alumis's oral TYK2 inhibitor outside psoriasis.

Moderna's mRNA-1010 flu vaccine heads toward 2026 filings beyond the US

Mon, 13 Jul 2026 17:43:14 GMT

Two positive Phase 3 readouts, including 26.6% relative efficacy over a licensed flu shot, underpin Moderna's plan to file mRNA-1010 in more countries this year as its US review runs toward an August 5 PDUFA date.

Moderna's mRNA-1010 flu shot clears FDA and Health Canada review acceptance

Mon, 13 Jul 2026 17:43:13 GMT

Phase 3 data show a 26.6% relative efficacy edge over a licensed flu vaccine, and regulators in the US, Canada, EU and Australia have taken the filing under review ahead of Moderna's first potential flu approval.

Neumora's NMRA-511 posts 0.34-effect size ahead of H2 2026 dose-finding data

Mon, 13 Jul 2026 17:43:04 GMT

A pre-specified analysis already showed effect sizes on agitation and aggression scores; the next readout tests whether higher doses in a MAD expansion cohort extend that signal.

Biohaven's opakalim epilepsy trial nears H2 2026 readout after two delays

Mon, 13 Jul 2026 17:42:56 GMT

RISE 3 has pushed its primary completion date twice since 2024, and Biohaven now points to second-half 2026 pivotal data testing a Kv7 activator with no direct approved comparator.

Viatris awaits Dec. 27 FDA verdict on non-opioid pain drug meloxicam-107A-02

Mon, 13 Jul 2026 17:42:51 GMT

Two positive Phase 3 trials backed the NDA for fast-acting meloxicam; the FDA's review now turns on whether that data supports a non-opioid first-line option for acute pain.

Spyre's SPY003 data will test if SKYLINE's IL-23 arm repeats SPY001's RHI win

Mon, 13 Jul 2026 17:42:43 GMT

Spyre expects induction data for its anti-IL23 antibody SPY003 in the SKYLINE ulcerative colitis trial by the end of Q3 2026, after SPY001 met its primary endpoint in the same platform study.

Incyte's early-stage JAK2V617F drug faces H2-2026 safety readout

Mon, 13 Jul 2026 17:42:41 GMT

INCB160058's Phase 1 trial will report dose-limiting toxicity and safety data in adults with myelofibrosis, polycythemia vera and essential thrombocythemia who failed prior therapy.

Traws Pharma resubmits TXM safety data to MHRA to unlock flu challenge trial

Mon, 13 Jul 2026 17:42:31 GMT

The Phase 2a study cannot begin dosing volunteers until UK regulators clear a reworked toxicology package Traws expects to refile by the end of September.

Ascletis moves ASC30 into diabetes as Phase 2 readout nears in Q3 2026

Mon, 13 Jul 2026 17:42:30 GMT

The oral GLP-1R agonist already posted positive obesity data; a 100-patient diabetes trial now tests whether that HbA1c-lowering profile extends to a second indication.

Praxis heads toward H2 2026 elsunersen readout in SCN2A epilepsy

Mon, 13 Jul 2026 17:42:27 GMT

EMBRAVE3 will test whether elsunersen cuts seizure frequency in infants with early-seizure-onset SCN2A DEE, a disease with no approved disease-modifying treatment.

Rapport pulls forward RAP-219 bipolar mania readout to Q4 2026

Mon, 13 Jul 2026 17:42:13 GMT

Rapport now expects topline YMRS data from its placebo-controlled Phase 2 trial months earlier than its prior 1H 2027 guidance, testing a mechanism with no direct comparator in bipolar mania.

Janux plans first JANX011 safety update in healthy volunteers by year-end

Mon, 13 Jul 2026 17:41:54 GMT

The Phase 1 trial testing Janux's CD19-directed ARM molecule in healthy adults is recruiting toward an October 2026 primary completion, with an initial update guided for the second half of the year.

FDA priority review sets Sept. 19 decision on AQNEURSA for A-T

Mon, 13 Jul 2026 17:41:12 GMT

IntraBio's supplemental filing seeks the first approved therapy for ataxia-telangiectasia, built on a 17-patient trial that later terminated after results posted.

IntraBio's AQNEURSA nears FDA verdict as first drug for A-T

Mon, 13 Jul 2026 17:41:09 GMT

The Phase 3 trial already showed a 1.88-point SARA benefit over placebo with p<0.001, and the FDA's September 19 priority review decides if that becomes the first approved A-T therapy.

Leads Biolabs to present LBL-024 first-line NSCLC cohort data in September

Mon, 13 Jul 2026 17:40:54 GMT

The PD-L1/4-1BB bispecific, already headed toward a BLA in another cancer, faces its first large first-line lung cancer readout as the Phase 2 trial keeps enrolling toward a December 2026 completion.

Rapport's RAP-219 long-term study feeds Phase 3 bet after 77.8% seizure cut

Mon, 13 Jul 2026 17:40:34 GMT

An open-label safety extension enrolling now will report preliminary data in H2 2026, testing durability of the seizure reduction that sent RAP-219 into two pivotal trials.

Aardvark's HERO trial for ARD-101 in PWS is suspended, completion slips a year

Mon, 13 Jul 2026 17:40:32 GMT

Aardvark kept guiding to a Q3 2026 readout even as its registry record shows the trial suspended and its completion date pushed from March 2026 to March 2027.

Adicet's ADI-001 RA update tests cell therapy without conditioning

Mon, 13 Jul 2026 17:40:31 GMT

Adicet expects an H2-2026 update on ADI-001 in treatment-refractory rheumatoid arthritis, a Phase 1 safety study probing whether its gamma delta T cell therapy can work without lymphodepletion.

Biohaven's pivotal epilepsy trial for opakalim heads toward H2 2026 readout

Mon, 13 Jul 2026 17:39:51 GMT

The first of two registrational studies testing the Kv7.2/7.3 activator against placebo in drug-resistant focal epilepsy is set to post results, building on tolerability data Biohaven says separates it from rival Kv7 activators.

Aligos' hepatitis B pill clears first futility check, DSMB expands cohort

Mon, 13 Jul 2026 17:39:13 GMT

The HBeAg-negative interim analysis avoided stopping for futility, prompting a DSMB-recommended enrollment expansion, while the HBeAg-positive interim central to B-SUPREME's design is still ahead in H2 2026.

Candel's biomarker study backs up its Phase 3 prostate cancer data, not the trial itself

Mon, 13 Jul 2026 17:39:07 GMT

A mechanistic Phase 2 study of CAN-2409 is set to report immune biomarker data in Q3 2026, supporting evidence for a BLA Candel plans to file on separate Phase 3 results.

Inmagene's IMG-007 atopic dermatitis trial pushes readout into 2027

Mon, 13 Jul 2026 17:38:41 GMT

The ADAPTIVE Phase 2b trial nearly doubled its enrollment target and slid its completion date 13 months, with topline EASI data now expected well past the original Q4 2026 guide.

Triveni Bio's TRIV-509 heads to Phase 2 atopic dermatitis data in Q4 2026

Mon, 13 Jul 2026 17:38:40 GMT

The kallikrein-targeting antibody has no validated same-mechanism precedent in atopic dermatitis, making a randomized, placebo-controlled Week 16 readout the first test of the biology in humans.

Vistagen's fasedienol repeat-dose trial nears a Q3 2026 SAD readout

Mon, 13 Jul 2026 17:38:21 GMT

The Phase 2 study tests whether repeat, as-needed dosing of Vistagen's intranasal fasedienol curbs acute social anxiety, following positive open-label extension data from its Phase 3 program.

Cullinan's CLN-978 heads toward first RA repeat-dosing data in Q3

Mon, 13 Jul 2026 17:38:18 GMT

The subcutaneous CD19xCD3 engager's OUTRACE RA trial is designed to test drug safety and B-cell depletion, not efficacy, in the first company-sponsored T-cell-engager data in autoimmune disease.

FDA priority review sets up Q3 verdict on rusfertide for polycythemia vera

Mon, 13 Jul 2026 17:38:14 GMT

Takeda and Protagonist's hepcidin mimetic faces an FDA decision built on Phase 3 VERIFY and Phase 2 REVIVE data, in a disease with no approved therapy that directly targets the mechanism driving red-cell overproduction.

AIM's DURIPANC trial nears full Ampligen dosing as pancreatic cancer readout builds

Mon, 13 Jul 2026 17:38:09 GMT

The Erasmus MC-run study of Ampligen plus AstraZeneca's Imfinzi finishes dosing in August, setting up a December clinical-benefit-rate readout in post-FOLFIRINOX pancreatic cancer.

FDA priority review of Jazz's Ziihera in first-line gastric cancer nears Aug. 25 decision

Mon, 13 Jul 2026 17:38:08 GMT

The sBLA rests on HERIZON-GEA-01, the only Phase 3 trial testing a HER2-directed regimen in this first-line population, with Breakthrough Therapy designation already in hand.

Sitryx completes enrollment early in Phase 1b oral PKM2 drug for eczema

Mon, 13 Jul 2026 17:37:45 GMT

SYX-5219 finished enrolling ahead of schedule and now heads to a Q4 2026 readout that will test whether early biomarker signals translate into clinical effect.

argenx moves toward oMG label after VYVGART beats placebo in ADAPT OCULUS

Mon, 13 Jul 2026 17:37:42 GMT

The Phase 3 trial hit its primary endpoint with a 4.04-point MGII PRO ocular score improvement versus 1.99 for placebo, setting up an sBLA argenx plans to file by the end of Q3 2026.

Vedanta's VE303 Phase 3 cleared its first futility check; a second test looms

Mon, 13 Jul 2026 17:37:36 GMT

RESTORATiVE303's data monitoring committee let the C. diff trial continue unmodified in April, and a second prespecified interim look is due later in 2026, well before the trial's 2027 completion.

Celldex's CDX-622 heads to Q3 data after early doses cut tryptase 50%

Mon, 13 Jul 2026 17:37:25 GMT

The Phase 1 trial has completed with 85 healthy volunteers; multiple-dose and subcutaneous data due by September will show whether the mast cell and TSLP signal holds beyond a single dose.

4DMT to show 4D-150's two-year wet AMD data ahead of pivotal readouts

Mon, 13 Jul 2026 17:37:14 GMT

PRISM's Phase 2b two-year results, due at a scientific conference in Q3 2026, will be the most mature look yet at 4D-150 before 4FRONT-1 topline data lands in H1 2027.

Profound's CAPTAIN trial heads toward a 2026 readout on TULSA vs. surgery

Mon, 13 Jul 2026 17:37:11 GMT

Profound Medical says results from its head-to-head prostate cancer trial against radical prostatectomy will publish in 2026, even as the trial's own registry record shows it still recruiting past its 2024 completion target.

Structure Therapeutics' aleniglipron extension data due after 16.2% interim win

Mon, 13 Jul 2026 17:36:49 GMT

The open-label ACCESS OLE study reports topline results in Q3 2026, testing whether the oral GLP-1 candidate's 56-week weight loss holds up as Structure moves it into Phase 3.

MBX Biosciences' obesity peptide posts 7% weight loss at 8 weeks in early look

Mon, 13 Jul 2026 17:36:37 GMT

A small blinded cohort from MBX 4291's Phase 1 trial hit 7% weight loss with no serious adverse events, ahead of 12-week data due by year-end.

Immutep's IMP761 healthy-volunteer trial pushes MAD readout to Q3 2026

Mon, 13 Jul 2026 17:36:25 GMT

The LAG-3 antibody's single-ascending-dose phase cleared safety at 14 mg/kg with no concerns, and the ongoing multiple-ascending-dose phase will test whether that tolerability holds at repeat dosing.

FDA reviews WINREVAIR label expansion off HYPERION's worsening-event data

Mon, 13 Jul 2026 17:36:21 GMT

Merck's sBLA rests on HYPERION's time-to-clinical-worsening result in newly diagnosed PAH, due September 21, 2026, even as the trial itself ended in Terminated status.

Scholar Rock's apitegromab faces Sept. 30 FDA decision on SMA muscle drug

Mon, 13 Jul 2026 17:36:18 GMT

The BLA rests on a Phase 3 trial the company says met its primary endpoint, with the September 30 PDUFA date now turning on manufacturing inspections rather than the clinical data.

uniQure to file AMT-130 BLA in Huntington's on accelerated-approval path

Mon, 13 Jul 2026 17:36:14 GMT

The FDA told uniQure the 3-year Phase I/II analysis can support a Huntington's disease BLA, but a confirmatory trial design isn't yet settled ahead of the Q3 2026 filing.

Disc Medicine's TMPRSS6 antibody heads toward first sickle cell safety data

Mon, 13 Jul 2026 17:35:49 GMT

The Phase 1b readout will test whether hepcidin induction is tolerable in sickle cell disease, a mechanism with no direct clinical precedent in this population.

BioMarin's VOXZOGO hits growth-velocity target in hypochondroplasia trial

Mon, 13 Jul 2026 17:35:36 GMT

The CANOPY-HCH-3 Phase 3 study showed a 2.33 cm/yr growth-velocity gain over placebo, setting up an FDA sNDA filing planned for the third quarter of 2026.

Clene plans ALS accelerated-approval NDA built on a biomarker, not survival data

Mon, 13 Jul 2026 17:35:06 GMT

FDA told Clene an NfL biomarker signal from small, partly aged trials may support filing, but the agency wants proof the biomarker predicts clinical benefit before approval.

Immunome to detail RINGSIDE's 84% progression-risk cut for varegacestat at ASCO

Mon, 13 Jul 2026 17:34:41 GMT

The Phase 3 desmoid tumor trial already met its primary endpoint; Immunome filed an NDA in April and will present full data as it awaits FDA review.

REGENXBIO clears dosing hurdle, sets up Q3 BLA for DMD gene therapy RGX-202

Mon, 13 Jul 2026 17:34:30 GMT

REGENXBIO finished dosing its confirmatory study ahead of schedule after RGX-202 hit its microdystrophin biomarker target in the pivotal cohort, teeing up an accelerated-approval filing built on a surrogate endpoint.

Teva's IL-15 antibody nears celiac Phase 2a readout with enrollment complete

Mon, 13 Jul 2026 17:34:25 GMT

TEV-53408 finished enrollment at 50 patients and Teva has guided to H2 2026 topline data testing whether blocking IL-15 can reverse villous atrophy in celiac disease.

Rein Therapeutics' LTI-03 IPF safety data due as trial re-enrolls after FDA hold

Mon, 13 Jul 2026 17:34:18 GMT

The Phase 2 RENEW trial resumed U.S. enrollment after an FDA clinical hold, with initial safety and tolerability data expected as the sole clinical-stage test of a Caveolin-1 mechanism in IPF.

Immix's NXC-201 hits 95% complete response rate ahead of September update

Mon, 13 Jul 2026 17:33:17 GMT

NEXICART-2's interim data show 19 of 20 evaluable AL amyloidosis patients converted to complete response, with the next update due in September testing whether that rate holds as more patients mature.

Bolt delays BDC-4182 gastric cancer data to Q3 2026 for step-up dosing fix

Mon, 13 Jul 2026 17:33:14 GMT

A protocol change to add step-up dosing after early immune activity pushed Bolt Biotherapeutics' first BDC-4182 data behind a workforce cut and a cash runway extended into 2027.

Spyre's SPY072 nears first RA data for an anti-TL1A antibody in Q3 2026

Mon, 13 Jul 2026 17:33:04 GMT

Enrollment in the SKYWAY-RD RA sub-study is complete, and Spyre has no in-class rival past Phase 2, making the DAS28-CRP readout the first human proof-of-concept test for TL1A in rheumatoid arthritis.

SonoClear device data on tumor-margin imaging head to EANS in October

Mon, 13 Jul 2026 17:33:03 GMT

A pivotal multicenter study of SonoClear's acoustic coupling fluid, which carries FDA Breakthrough Device status, will be presented at a European neurosurgery congress ahead of a still-pending US clearance.

Cellectar targets Q3 2026 EU filing for iopofosine I 131 in Waldenstrom's

Mon, 13 Jul 2026 17:32:57 GMT

The submission rests on the CLOVER-WaM Phase 2 study, whose primary completion date has slipped six times since 2020 and now lands on the eve of the planned filing.

Fractyl's Revita faces its first randomized weight-maintenance test in Q3

Mon, 13 Jul 2026 17:32:45 GMT

REMAIN-1 Midpoint Cohort data due by September 30 will show whether a duodenal-lining procedure can hold weight loss after patients stop tirzepatide, a question with no approved answer yet.

Candel to unveil biomarker data from Phase 3 prostate gene therapy in Q3

Mon, 13 Jul 2026 17:32:35 GMT

The readout follows extended survival follow-up already promised for aglatimagene besadenovec, with a BLA submission planned before any of that data is public.

AbCellera heads toward Q3 readout for first-in-class menopause antibody

Mon, 13 Jul 2026 17:32:26 GMT

ABCL635's Phase 2 efficacy data will be the first test of whether an NK3R antibody can reduce hot flashes, after favorable Phase 1 safety and PK data in May.

Ocugen's OCU410ST gene therapy nears Stargardt interim readout with no rival past Phase 2

Mon, 13 Jul 2026 17:32:12 GMT

The Q3 2026 GARDian3 interim data will test a subretinal gene therapy that stands alone in advanced clinical testing for ABCA4-linked Stargardt disease.

NorthSea's orziloben nears Q3 readout in rare liver disease IFALD

Mon, 13 Jul 2026 17:32:10 GMT

A 36-patient Phase 2 trial testing whether orziloben eases cholestasis and fibrosis in intestinal failure-associated liver disease is set to read out with no approved therapy in the field to beat.

PharmaEssentia's BESREMi faces Aug. 30 FDA decision in essential thrombocythemia

Mon, 13 Jul 2026 17:32:09 GMT

The sBLA seeks the first U.S. label expansion of an already-approved interferon into a second blood-cancer indication, with Taiwan's approval in hand and no BESREMi-specific data disclosed yet.

Telix's PET imaging agent TLX101-Px faces Sept. 11 FDA decision for glioma

Mon, 13 Jul 2026 17:32:09 GMT

The NDA for TLX101-Px, an F-18 PET tracer to distinguish tumor regrowth from treatment effect in glioma, carries Fast Track and Orphan Drug status ahead of its September 11 PDUFA date.

FDA to decide on Ionis's zilganersen for Alexander disease by Sept. 22

Mon, 13 Jul 2026 17:32:08 GMT

The priority review rests on a pivotal trial that showed a 33.3% gait-speed benefit over control, a result that would make zilganersen the first approved treatment for the disease.

Travere's HARMONY Restarts After 20-Month Delay, Reads Out H2 2027

Mon, 13 Jul 2026 17:30:35 GMT

The Phase 3 pegtibatinase trial resumed dosing in early 2026 after its primary completion date slipped nearly two years, with a homocysteine-lowering bar the model rates 98.5% likely to hit but only 24.5% likely to matter clinically.

Vaxart's Oral COVID Vaccine Faces First Efficacy Test Against mRNA Shot in 2027

Mon, 13 Jul 2026 17:30:34 GMT

The Phase 2b readout will be the first data on whether Vaxart's oral pill vaccine can beat a commercial mRNA booster on infection prevention, a bar the AppliedXL model puts at 49.4%.

Nektar's Rezpeg Faces a Durability Test as Off-Treatment Data Loom in Q1 2027

Mon, 13 Jul 2026 17:30:34 GMT

The Week 16 win already reported is now old news: REZOLVE-AD's next readout must show whether rezpegaldesleukin's effect holds 52 weeks after dosing stops, the question Phase 3 planning cannot answer alone.

MannKind's inhaled nintedanib clears Cohort 1 safely, awaits IPF efficacy data

Mon, 13 Jul 2026 17:30:33 GMT

Cohort 1 of the Phase 1b INFLO-1 study finished enrollment with no discontinuations or serious adverse events, leaving lung-function and tolerability data as the test of whether an inhaled version of nintedanib can match the oral drug's profile.

ProMIS's PMN310 clears to top dose in Alzheimer's trial with no drug-related SAEs so far

Mon, 13 Jul 2026 17:30:33 GMT

PRECISE-AD has finished enrolling 144 patients and cleared its safety board to the highest planned dose, setting up a Q3 2026 interim analysis ahead of full topline data.

Genelux's OnPrime ovarian cancer trial slips again, pushing PFS data to late 2026

Mon, 13 Jul 2026 17:30:32 GMT

Genelux has pushed the OnPrime Phase 3 completion date three times since 2024, and the PFS readout for its oncolytic virus Olvi-Vec now depends on a trial still recruiting less than six months from its new target.

Kyverna's one-year SPS data will test if 46% T25FW gain at 16 weeks holds up

Mon, 13 Jul 2026 17:30:32 GMT

KYSA-8 already hit its primary endpoint with a 46% median walk-speed improvement at Week 16; the H2 2026 update tests whether that effect persists through one year as Kyverna files a rolling BLA.

Axsome pushes SUSTAIN shift-work-disorder readout guidance from 2026 to 2027

Mon, 13 Jul 2026 17:30:32 GMT

The Phase 3 SUSTAIN trial's completion date has not moved, but Axsome's own Q1 2026 guidance now points to 2027, a signal the model's 98.5% endpoint read does not capture.

Connect Biopharma's rademikibart COPD readout faces model coin-flip on treatment failure rate

Mon, 13 Jul 2026 17:30:31 GMT

The Phase 2 Seabreeze STAT trial has slipped its primary completion date twice, and AppliedXL puts the endpoint-met odds at 49.4% for a placebo-controlled study of a mechanism untested in acute COPD exacerbation.

Vaxart's oral COVID pill faces efficacy readout after 16-month completion date slip

Mon, 13 Jul 2026 17:30:31 GMT

The Phase 2b comparative efficacy data due in Q4 2026 will test whether VXA-CoV2-3.3 beats an mRNA booster, but enrollment fell 45% and the primary completion date moved to May 2027.

Harmony's Dravet Trial Hits Year Seven With Completion Pushed to 2027

Mon, 13 Jul 2026 17:30:31 GMT

EPX-100's Phase 3 primary completion date has slipped 66 months since 2021 as enrollment grew fivefold, raising the bar for what a 2026 readout can actually show.

PALIZADE Data Already Show 42% CRR Rate Before Kezar's Terminated Trial Closes Out

Mon, 13 Jul 2026 17:30:30 GMT

Kezar's Phase 2b lupus nephritis trial was terminated in November 2024, but ClinicalTrials.gov results already show a Week 25 renal response signal; the AppliedXL model puts endpoint-met probability at 4.1%.

Exelixis's STELLAR-304 Faces a Fourth Slip Before H2-2026 RCC Readout

Mon, 13 Jul 2026 17:30:29 GMT

The Phase 3 trial hit its enrollment target and completed its 2025 primary completion date, but topline guidance has moved four times since 2025 as the model assigns 91.4% for meeting the endpoint against a competitive readout window.

Karyopharm's Selinexor Trial Cuts Enrollment 58% Ahead of H2 2026 Readout

Mon, 13 Jul 2026 17:30:29 GMT

XPORT-MM-031 shrank from 222 to 117 patients and slipped 41 months on completion timing before its event-driven PFS readout, a backdrop the 91.4% endpoint-met model score does not price in.

Axsome's SUSTAIN Readout Slips to 2027 as Sunosi Franchise Awaits Successor Data

Mon, 13 Jul 2026 17:30:28 GMT

The Phase 3 shift work disorder trial for solriamfetol has no posted results and a 2026 guidance date already missed, with the AppliedXL model's 98.5% endpoint-met read resting on trial-design features rather than any disclosed efficacy signal.

Vera's atacicept already hit its Phase 3 bar; 2027 readout tests durability

Mon, 13 Jul 2026 17:30:28 GMT

ORIGIN 3 met its week 36 proteinuria endpoint with a 42% placebo-adjusted UPCR reduction in 2025; the 2027 two-year data will show whether that benefit holds and whether kidney function follows.

ProMIS's PMN310 heads toward 2027 readout after full, on-time AD enrollment

Mon, 13 Jul 2026 17:30:28 GMT

PRECISE-AD finished enrolling 144 Alzheimer's patients on schedule with no treatment-related serious adverse events, setting up 12-month biomarker and safety data against a field where amyloid antibodies carry a real ARIA burden.

Harmony's ARGUS Dravet Trial Enrolls to 150 After Six-Year Slip to 2027

Mon, 13 Jul 2026 17:30:27 GMT

The Phase 3 study has moved its primary completion date seven times and grown enrollment 525%, leaving the 1H 2027 readout window resting on an operationally unstable protocol.

Nanoscope to show 3-year MCO-010 data as BLA sits with FDA

Mon, 13 Jul 2026 17:30:27 GMT

The ASRS presentation adds durability follow-up to a trial that already reported its primary result, arriving after Nanoscope says it has submitted a BLA for the gene therapy in retinitis pigmentosa.

Voronoi opens Phase 1/2 trial testing oral EGFR drug against C797S resistance

Mon, 13 Jul 2026 15:45:47 GMT

VRN110755 enters the clinic in a field crowded with EGFR-mutant NSCLC programs, aiming at resistance mutations that current third-generation inhibitors don't cover.

Chia Tai Tianqing registers dose-finding trial of TQB3126 in breast cancer

Mon, 13 Jul 2026 15:45:33 GMT

The Phase 1/2 study will test safety and an early dose before any efficacy signal can inform the crowded HER2, TROP2 and PD-1/PD-L1 breast cancer field.

BioNTech registers Phase 1 HIV vaccine trial with an analytical treatment interruption

Mon, 13 Jul 2026 15:45:12 GMT

BNT168 will be tested in people with and without HIV, including a supervised pause in antiretroviral therapy to gauge immune control of the virus.

Chengdu Suncadia opens dosing in first-in-human trial of HRS-1635 in B-cell cancers

Mon, 13 Jul 2026 15:44:59 GMT

The Phase 1 study will test dose-limiting toxicity across relapsed or refractory B-cell malignancies, with a 2028 primary completion date and no disclosed target for HRS-1635.

AnHorn Medicines starts first human dosing of AH-008, an IV antibody candidate

Mon, 13 Jul 2026 15:44:53 GMT

A single-site Phase 1 in healthy volunteers will test AH-008's safety and pharmacokinetics, the first clinical readout for AnHorn's newest program.

Chengdu Suncadia registers first Phase 1 study of small molecule HRS-8797

Mon, 13 Jul 2026 15:44:47 GMT

The healthy-volunteer trial will test safety and pharmacokinetics of HRS-8797, the sponsor's first clinical study of the compound, with a primary completion date of December 2026.

Kelun-Biotech adds a fourth NSCLC combination trial for sacituzumab tirumotecan

Mon, 13 Jul 2026 15:36:23 GMT

The new Phase 2 study pairs the TROP2 antibody-drug conjugate with SKB118 and folds into a lung-cancer program Merck already runs three later-stage trials against.

Hutchmed advances HMPL-760 PK study to active phase in China

Mon, 13 Jul 2026 15:34:59 GMT

A 24-subject Phase 1 study testing how food and a proton pump inhibitor affect HMPL-760 absorption has moved to active status, with data due around October 2026.

Biomissile registers BM230-PD-1 trial for HER2 tumors, an untested pairing

Mon, 13 Jul 2026 15:26:25 GMT

The Phase Ib/II study is the first industry trial to combine BM230 with a PD-1 inhibitor across eight HER2-linked solid tumors, entering a target field otherwise led by antibody-drug conjugates.

Haisco opens second HSK41959 trial, pairing PRMT5 drug with chemo

Mon, 13 Jul 2026 15:25:24 GMT

The Chinese oncology sponsor moves its MTAP-deletion PRMT5 inhibitor into combination testing in NSCLC and pancreatic cancer, following a still-recruiting monotherapy study.

Huilun starts Phase 2/3 trial of oral HL-1186 for post-surgical pain in China

Mon, 13 Jul 2026 15:25:10 GMT

The 330-patient trial will test whether HL-1186 beats placebo on a 48-hour pain-relief score, entering a postoperative-pain field still built on opioids and older local anesthetics.

Larkspur opens dosing in first-in-human trial of oral LRK-4189 for advanced tumors

Mon, 13 Jul 2026 15:25:09 GMT

The Phase 1/2 study moved to recruiting with enrollment unchanged at 120, starting a safety and dose-finding trial with a primary completion date of June 2029.

Beijing QL adds cardiac-safety trial for obesity candidate zovaglutide

Mon, 13 Jul 2026 15:15:31 GMT

The Phase 1 QTc study in healthy adults is a routine regulatory checkbox that will feed the safety package behind zovaglutide's Phase 3 obesity program.

Serum CTRP7 tracks kidney damage severity, tied to dapagliflozin benefit in DKD

Mon, 13 Jul 2026 13:13:00 GMT

A 108-patient cross-sectional study links rising CTRP7 to worsening diabetic kidney disease, and a 48-patient follow-on ties 12 weeks of dapagliflozin to lower albuminuria and reduced oxidative stress markers.

Spark tAN device raises platelet activity in ear-nerve stimulation study

Mon, 13 Jul 2026 13:00:00 GMT

A 30-person first-in-human study found Spark Biomedical's non-invasive ear stimulation increased platelet function without triggering clotting risk, a hemostasis mechanism with no direct precedent in this class.

Sana's hypoimmune islet cells still working without immune drugs at 14 months

Mon, 13 Jul 2026 12:00:00 GMT

A NEJM letter details 14-month follow-up on the first human dosed with UP421, showing the HIP-modified islets survived, evaded rejection and kept producing insulin without immunosuppression.

Cochlear's Osia 3 clears FDA on a 29-patient satisfaction result

Mon, 13 Jul 2026 11:07:00 GMT

The SONUS trial backing Cochlear's newest bone conduction processor reported 97% patient satisfaction with sound quality, but disclosed no comparative outcome, safety, or endpoint data against the Osia 2.

Posit Science's BrainHQ trial links brain training to acetylcholine marker

Mon, 13 Jul 2026 11:00:00 GMT

The completed INHANCE trial reported a PET imaging signal after speed-of-processing training, with no effect size or p-value disclosed on the record and no controlled comparator drug to benchmark it against.

Q32 Bio's bempikibart cuts SALT score 35.3% in Part B of severe alopecia trial

Mon, 13 Jul 2026 10:59:00 GMT

The open-label, 33-patient readout hit its primary endpoint with no comparator arm, and Q32 Bio now plans a registration-directed program in H1 2027.

ANI Pharmaceuticals' ILUVIEN hits both endpoints in chronic uveitis Phase 4 trial

Mon, 13 Jul 2026 10:50:00 GMT

The SYNCHRONICITY trial showed a 3.6-letter vision gain and a 157.5-micron drop in retinal thickness at six months, backing ILUVIEN's use in retina practices already prescribing it.

TolerogenixX Phase Ib safety data cited to back TOL-2 kidney tolerance program

Mon, 13 Jul 2026 08:00:00 GMT

A 14-patient Phase Ib readout completed nine years ago now anchors TolerogenixX's push for EU approval, with the real test, a 63-pair Phase IIb trial, due in H1 2027.

PVA microsphere rhinoplasty holds shape in 30 Asia female patients over 24 months

Mon, 13 Jul 2026 03:46:00 GMT

A single-arm case series links a surgical-like PVA microsphere injection technique to sustained nasal aesthetic gains and low regression, without a comparator arm.

Selinexor-tislelizumab shows 75% response after PD-1 blockade failure in NK/T-cell lymphoma

Mon, 13 Jul 2026 01:13:00 GMT

The phase 1b TOUCH trial reports a 75% overall response and 43.8% complete response in 16 checkpoint-exposed patients with relapsed NK/T-cell lymphoma, a population with no established second-line standard.

HUTCHMED completes HMPL-453 drug-interaction study as pivotal ICC data already read out

Mon, 13 Jul 2026 00:00:00 GMT

The Phase 1 itraconazole and rifampin interaction study finished on schedule, arriving after fanregratinib's pivotal trial already reported a 42.5% response rate in FGFR2-fusion bile duct cancer.

Shionogi completes Phase 1 pharmacokinetic study of oral S-892216 in renal impairment

Mon, 13 Jul 2026 00:00:00 GMT

The trial enrolled 24 participants across renal-function and hemodialysis cohorts to measure how kidney disease alters drug exposure, with results not yet posted.

Shionogi completes Phase 1 renal-impairment PK study of S-892216

Mon, 13 Jul 2026 00:00:00 GMT

The trial enrolled 24 of a planned 40 participants and finished with pharmacokinetic data now due, testing how kidney function and dialysis affect drug clearance.

FDA approves Merck's Keytruda plus Padcev for muscle-invasive bladder cancer

Fri, 10 Jul 2026 18:10:00 GMT

The approval, weeks ahead of its August 17 PDUFA date, rests on a 47% reduction in disease progression or death versus chemotherapy before and after surgery.

Bausch + Lomb's BL1107 eye drop fails glaucoma vision-function goal

Thu, 09 Jul 2026 20:30:00 GMT

The Phase 2 study lowered eye pressure but missed its visual-field endpoint and key vision secondaries, and Bausch + Lomb is dropping the topical program to focus on an implant for geographic atrophy instead.

LEO Pharma's tralokinumab clears PK bar in atopic dermatitis children aged 6 to 11

Thu, 09 Jul 2026 15:00:00 GMT

TRAPEDS-1 met its pharmacokinetic objective in 28 children, but the enrollment target was cut nearly in half during the trial and no efficacy data have been released.

Elysium's 7-day supplement pilot ties Basis to menopause symptom drops

Thu, 09 Jul 2026 12:35:00 GMT

A 40-woman open-label study with no control arm reported 50%-plus self-reported symptom reductions and a shifted estrogen ratio, results the sponsor now wants a randomized trial to confirm.

Astellas builds on IZERVAY's GATHER1 win with new driving and biomarker data

Thu, 09 Jul 2026 12:00:00 GMT

The original GATHER1 result behind IZERVAY's approval is now dated, but Astellas is layering pooled follow-up data on driving eligibility and photoreceptor biomarkers to extend the case at ASRS 2026.

Forte's FB102 hits Week 24 vitiligo endpoint in placebo-controlled Phase 1b

Thu, 09 Jul 2026 12:00:00 GMT

FB102 produced a 29.6% mean facial-VASI improvement versus 7.9% for placebo at Week 24, with gains still building after the 12-week dosing period ended.

Astellas GATHER2 data confirm IZERVAY slowed GA growth, already an approved drug

Thu, 09 Jul 2026 12:00:00 GMT

Astellas says avacincaptad pegol met its GA-growth primary endpoint in GATHER2, replicating the effect that already won IZERVAY approval, without disclosing new effect sizes.

Tris Pharma says cebranopadol beat placebo on pain in Phase 3 ALLEVIATE-1

Thu, 09 Jul 2026 11:30:00 GMT

The launch of a new pain-drug subsidiary carried the topline result, but Tris Pharma disclosed no effect size, p-value, or safety data behind the win.

Tris Pharma's cebranopadol beats placebo on pain in second Phase 3 bunionectomy trial

Thu, 09 Jul 2026 11:30:00 GMT

ALLEVIATE-2 hit its primary pain endpoint and cut opioid rescue use, giving the dual NOP/MOP agonist two positive Phase 3 readouts as Tris Pharma's Adneuris unit prepares an NDA.

InxMed's ifebemtinib-garsorasib combo posts 82% ORR in first-line KRAS G12C NSCLC

Thu, 09 Jul 2026 09:28:00 GMT

The chemotherapy-free oral pairing hit a response rate and 22.3-month PFS no first-line KRAS G12C regimen has cleared, in a 33-patient single-arm cohort now moving to Phase 3 confirmation.

Ionis and AstraZeneca's eplontersen misses primary endpoint in ATTR-CM trial

Thu, 09 Jul 2026 06:00:00 GMT

CARDIO-TTRansform did not beat placebo on CV death and recurrent events in 1,432 patients, though a monotherapy subgroup and TTR reduction data complicate the read.

Ipsen's Dysport hits primary endpoint in chronic migraine Phase 3

Thu, 09 Jul 2026 05:00:00 GMT

C-BEOND met its week-24 monthly-migraine-day endpoint versus placebo, positioning Dysport as a candidate first-in-class botulinum toxin across both migraine types.

Ipsen's Dysport hits primary endpoint in Phase 3 episodic migraine trial

Thu, 09 Jul 2026 05:00:00 GMT

E-BEOND is the first Phase III trial of a botulinum toxin to show a statistically significant cut in monthly migraine days versus placebo in episodic migraine.

Betta's ensartinib cuts ALK-positive NSCLC recurrence risk 80% in Phase 3

Thu, 09 Jul 2026 02:16:00 GMT

The ELEVATE trial's adjuvant ensartinib arm hit 86.4% 2-year disease-free survival versus 53.5% on placebo, and Betta says China has already accepted its marketing application.

Tarsus-acquired IRX-101 cuts injection pain and corneal damage versus iodine antiseptic

Wed, 08 Jul 2026 20:05:00 GMT

The completed 154-patient RELIEF trial hit statistical significance on pain and corneal staining, but the trial's own registered safety endpoint result was not disclosed in the acquisition announcement.

Beurer's heat device cut mosquito-bite itch nearly in half in small trial

Wed, 08 Jul 2026 16:38:00 GMT

A 22-person German registry trial and a 1,750-person published study both tie concentrated heat applied to the bite site to faster itch relief than no treatment, with no drug involved.

Octapharma's wilate wins FDA nod for VWD prophylaxis in kids under 6

Wed, 08 Jul 2026 14:21:00 GMT

The expanded approval rests on a 12-patient Phase 3 trial showing an annualized bleeding rate of 4.6, with no thrombotic events, in the first VWF concentrate cleared for prophylaxis across all VWD ages.

Cardiac Dimensions touts 10-year survival data from single-center mitral device study

Wed, 08 Jul 2026 14:05:00 GMT

A single-center extension of the completed REDUCE FMR trial reports 66% ten-year survival with no control comparison, as the sponsor's real evidence for U.S. approval now rests on the ongoing sham-controlled EMPOWER trial.

Miach's BEAR implant registry shows 5% ACL retear rate at two years

Wed, 08 Jul 2026 13:06:00 GMT

Modified surgical technique tracked with the same 5% retear rate seen in a published 100-patient cohort and cut reoperations, but the Bridge Registry has no comparator arm.

Eledon's tegoprubart: all evaluable islet-transplant patients reach insulin independence

Wed, 08 Jul 2026 13:00:00 GMT

An investigator-initiated Chicago trial reports every evaluable patient off insulin more than four weeks post-transplant, with no graft rejection, though the readout comes from a press release, not a peer-reviewed dataset.

Lilly secures Canada-wide reimbursement pathway for Ebglyss in eczema

Wed, 08 Jul 2026 13:00:00 GMT

A pCPA letter of intent follows CDA-AMC's conditional recommendation, opening public drug-plan access nationally for a Phase 3-proven IL-13 blocker already approved by Health Canada.

Chemomab's nebokitug hits safety bar in PSC as sponsor merges to pivot into RA

Wed, 08 Jul 2026 11:35:54 GMT

The Phase 2 SPRING trial met its primary safety endpoint and showed biomarker improvement in primary sclerosing cholangitis, but Chemomab is folding into Scipher Medicine to chase a 2028 rheumatoid arthritis readout instead.

Keenova's XIAFLEX hits pain endpoint in first pivotal trial for Ledderhose disease

Wed, 08 Jul 2026 11:00:00 GMT

The Phase 3 STRIDE trial met its primary pain endpoint and key secondary measures, positioning Keenova to file the first drug application for plantar fibromatosis in the fourth quarter of 2026.

Seres' SER-155 hits 80% response rate in checkpoint-inhibitor colitis pilot

Wed, 08 Jul 2026 11:00:00 GMT

A 15-patient investigator-run trial at Memorial Sloan Kettering found most patients cleared diarrhea without steroids, but the benefit faded by Day 43 for more than half.

Satellos shows fat-fraction drop, strength stability in 4 DMD adults on SAT-3247

Wed, 08 Jul 2026 10:30:00 GMT

Six-month TRAILHEAD data in four adults link SAT-3247 to reduced muscle fat and stable strength, but the interim readout carries no p-values and no comparator in a disease with no cure.

FDA grants accelerated approval to Vera's TRUTAKNA for IgA nephropathy

Tue, 07 Jul 2026 16:37:46 GMT

The approval rests on a 42% proteinuria reduction versus placebo from an interim ORIGIN 3 analysis, making TRUTAKNA the first dual BAFF and APRIL inhibitor cleared for the disease.

LifeMine's LIFE-001 Phase 1 grows to 160 as timeline slips 286 days

Tue, 07 Jul 2026 15:26:00 GMT

A third enrollment increase and a second completion-date push mark a highly unstable healthy-volunteer trial feeding a 65.1% endpoint-met read on a safety-only bar.

InSilico's AI-Designed Rentosertib Enters Phase 3 in IPF, First for TNIK Target

Tue, 07 Jul 2026 15:25:37 GMT

The registrational trial tests whether an AI-generated drug against an undrugged target, TNIK, can slow lung function decline where a crowded antifibrotic field has struggled.

Tiziana registers nasal foralumab ALS trial with no placebo control listed

Tue, 07 Jul 2026 15:25:36 GMT

The 44-patient BANYAN study will test safety and microglial biomarkers within the Healey ALS Platform, not efficacy, and no primary endpoint or competitor has ever tested this CD3 agonist in ALS.

Zai Lab expands ZL-1310 trial to 166 patients after 38.2% ORR in NEC data

Tue, 07 Jul 2026 15:25:30 GMT

The enrollment increase follows preliminary Phase 1b data showing a 38.2% response rate in extrapulmonary neuroendocrine carcinoma, but the trial has changed primary completion dates twice and grown enrollment three times since March 2025.

QuantX opens dosing in first-in-human QX-4533 trial, target undisclosed

Tue, 07 Jul 2026 15:25:19 GMT

The Phase 1 study moved to Recruiting with no mechanism, target, or indication named, leaving safety data due December 25, 2026 as the only near-term signal.

Insilico's TNIK inhibitor posts +98.4 mL FVC edge, advances to Phase III in IPF

Tue, 07 Jul 2026 13:43:00 GMT

GENESIS-IPF's Phase IIa readout on rentosertib cleared its safety bar and showed a FVC signal versus placebo, and Insilico has now moved the once-daily oral drug into a 320-patient Phase III trial.

Oragenics reports no serious adverse events yet in ONP-002 concussion trial

Tue, 07 Jul 2026 12:30:00 GMT

The July update activates all three Australian sites and clears a safety bar, but leaves the symptom-reduction result that defines the Phase 2a trial for a Q4 2026 readout.

Veru's enobosarm preserves lean mass with GLP-1 in Phase 2b, but posts no numbers

Tue, 07 Jul 2026 12:30:00 GMT

The QUALITY trial reported lean-mass and fat-loss benefits with enobosarm plus semaglutide in older adults, yet Veru disclosed no effect size, p-value, or safety data.

Hengrui's oral GLP-1 pill HRS-7535 hits 10.9% weight loss in China Phase 3

Tue, 07 Jul 2026 11:00:00 GMT

HARBOR-1 met its primary endpoint against placebo, positioning the oral small molecule among the first Phase 3 obesity readouts for this drug class in China.

Hengrui's oral HRS-7535 matches dapagliflozin on HbA1c in Phase 3 diabetes trial

Tue, 07 Jul 2026 11:00:00 GMT

OUTSTAND-2 hit its non-inferiority bar against dapagliflozin, and the 90 mg dose topped it on HbA1c, positioning an oral GLP-1 pill against China's SGLT2 standard of care.

Compass's COMP360 holds depression benefit to 26 weeks after two doses

Tue, 07 Jul 2026 10:30:00 GMT

39% of patients on the 25 mg dose sustained a meaningful MADRS improvement from Week 6 through Week 26 in COMP006, as Compass moves toward a Q4 2026 NDA filing.

TIXiMED's TIX100 clears Phase 1a safety bar, moves to 28-day dosing study

Tue, 07 Jul 2026 10:00:00 GMT

The oral TXNIP inhibitor was well tolerated across four single-dose cohorts and lowered post-meal glucose swings in healthy volunteers, clearing the way for a placebo-controlled multiple-dose study.

Xeltis launches aXess in Europe on 12-month patency data matching mature AVFs

Tue, 07 Jul 2026 07:30:00 GMT

The European pivotal readout reported patency comparable to matured fistulas and fewer reinterventions than historical grafts, but posted no numeric results or comparator arm alongside the launch.

Cyllene reports sustained incontinence drop with EG110A gene therapy in 16-patient trial

Tue, 07 Jul 2026 05:30:00 GMT

The Phase 1/2 readout in spinal-cord-injury patients reports durable incontinence reductions at 9 months, but Cyllene disclosed no incidence numbers, p-values, or comparator data.

Guangdong Hongzhi's Knee Osteoarthritis Trial Completes, No Results Posted

Tue, 07 Jul 2026 00:00:00 GMT

NCT06869200 finished this small, single-country device trial in China against a growth-factor kit rival Platelet-Rich Plasma, but the registry carries no WOMAC or VAS data yet.

Pharmasaga's PS1 Phase 1 completes with no posted results after 1,614 days

Tue, 07 Jul 2026 00:00:00 GMT

The Taiwan trial cleared completion four years after first-in-human start, but ClinicalTrials.gov shows no posted safety, PK, or dose-escalation data yet.

Lingyi Biotech registers third GBA1 gene therapy trial for Parkinson's, joins crowded field

Mon, 06 Jul 2026 16:06:44 GMT

The Early Phase 1 China study enters a target-indication pairing with a 100% termination rate to date, testing safety before any efficacy signal in 18 patients.

OnKure stops enrolling PIKture-01 and pushes OKI-219 completion to December 2026

Mon, 06 Jul 2026 16:05:42 GMT

The PI3Kα inhibitor trial closed enrollment at 200 patients and slid its primary completion date by seven months, as OnKure holds to a year-end 2026 data readout.

BMS pushes BMS-986470 sickle cell readout 480 days as enrollment target grows 22%

Mon, 06 Jul 2026 16:05:22 GMT

Bristol-Myers Squibb's early-stage HbF-inducer trial now completes April 2028, not January 2027, alongside a jump from 184 to 224 participants and a safety-primary design that will not settle efficacy.

Tango's TNG260 trial closes enrollment as third completion-date push lands

Mon, 06 Jul 2026 15:56:31 GMT

The STK11-mutant lung cancer study has slipped its primary completion date three times since 2023, with the bar for a Phase 2 dose still resting on a five-patient subgroup signal.

AlphaMol Science files first-in-human trial for CSU drug Alpha-0261

Mon, 06 Jul 2026 15:56:09 GMT

The Phase Ib registration gives no target, no primary endpoint efficacy bar and no comparator arm, leaving safety in a 48-patient cohort as the only near-term signal.

Hansoh Opens Enrollment for HS-20122 Combo in EGFR-Mutant NSCLC

Mon, 06 Jul 2026 15:56:06 GMT

The Phase 1b trial moved to recruiting status with a 2028 primary completion date, entering a crowded EGFR field where Osimertinib and six other direct comparators already run late-stage studies.

OnKure pushes OKI-219 first-in-human readout to end of 2026 as enrollment closes

Mon, 06 Jul 2026 15:55:46 GMT

The PI3K-alpha inhibitor's completion date slipped seven months to December 31, 2026, right as the trial stopped recruiting at 200 patients, with no efficacy data yet disclosed.

Jacobio Registers 32-Patient Phase 2a for JAB-8263 in Rheumatoid Arthritis

Mon, 06 Jul 2026 15:47:31 GMT

The undisclosed-target compound enters a small, safety-first study with no comparator arm, leaving efficacy, mechanism, and competitive positioning unresolved.

Biostar registers Phase 3 pitting Utidelone capsule against its own injection

Mon, 06 Jul 2026 15:46:44 GMT

The China-only trial tests a formulation switch, not a new mechanism, with no posted primary endpoint threshold and enrollment not yet started.

Minghui advances MH004 to Phase 3 in vitiligo, avoiding the JAK route

Mon, 06 Jul 2026 15:46:34 GMT

The 405-patient trial bets a topical, non-JAK mechanism can beat AbbVie, Pfizer, and Incyte JAK inhibitors on F-VASI75, but Minghui has not disclosed its target.

Hangzhou Zhongmei Files Generic-Style Roflumilast Trial for China Seborrheic Dermatitis

Mon, 06 Jul 2026 15:45:52 GMT

The Phase 3 study copies Arcutis's approved Zoryve regimen almost exactly, testing whether a Chinese sponsor can replicate an 79.5%-versus-58.0% precedent rather than break new clinical ground.

GenSci144 Enters Crowded PKU Field with a 48-Patient Safety-Only Phase 1

Mon, 06 Jul 2026 15:45:42 GMT

Changchun GeneScience starts a single-dose safety study for an undisclosed-mechanism small molecule, joining at least eight active PKU trials with no comparator arm to judge it against.

EnnovaBio starts first-in-human trial of topical ENC0653 in China

Mon, 06 Jul 2026 15:45:23 GMT

The Phase 1 safety study enrolls 56 healthy volunteers with no disclosed target or indication, leaving the program's competitive position and mechanism undefined.

Gensciences starts second FRSW107 Phase 3, adding to a crowded Factor VIII field

Mon, 06 Jul 2026 15:35:57 GMT

The China-only 60-patient trial tests annualized bleed rate against a landscape scored 'challenging,' with no comparator arm and no model read yet on record.

IBR854 shows no dose-limiting toxicity in 19-patient NK cell trial for tumors

Mon, 06 Jul 2026 11:14:00 GMT

The first-in-human, open-label study of a 5T4-targeted allogeneic NK cell therapy reported a 43.8% disease control rate but only 43 days of median progression-free survival, leaving durability unresolved.

Dragonboat cuts Phase 1 target 91% to 12 patients, closes trial with no posted data

Mon, 06 Jul 2026 00:00:00 GMT

NCT04739111 finished with 12 of a planned 130 patients and no results on ClinicalTrials.gov, leaving the dose-finding readout for Dragonboat's PD-L1/EGFR combination undisclosed.

Dragonboat's LDP trial cut enrollment 79% and posted no results at completion

Mon, 06 Jul 2026 00:00:00 GMT

NCT04718584 closed as Completed with enrollment slashed from 127 to 27 and no ClinicalTrials.gov results posted, leaving the pCR and ORR endpoints unresolved.

Dragonboat's PD-L1 trial cuts enrollment 49.2% to 66 after status lapsed to unknown

Mon, 06 Jul 2026 00:00:00 GMT

NCT03908814 closed out with less than half its original 130-patient target and no posted results, leaving the dose-finding data from LDP undisclosed three years after primary completion.

Huadong's China Phase 3 Roflumilast Cream Completes; No Results Posted Yet

Mon, 06 Jul 2026 00:00:00 GMT

The trial closed against a vehicle comparator with a primary endpoint that already cleared bar twice for Arcutis in the US, but Huadong has not disclosed a topline result.

Neumora's Navacaprant Trial Completes as Prior Phase 3 Cousin Already Failed

Mon, 06 Jul 2026 00:00:00 GMT

NCT06058039 finished with 422 patients and no posted results, arriving after Neumora's KOASTAL-1 missed its MADRS endpoint against placebo in December 2024.

Orelabrutinib cuts CLL progression risk 68% versus chlorambucil-rituximab

Sun, 05 Jul 2026 23:20:00 GMT

The Phase 3 ICP-022 trial hit its primary endpoint with a hazard ratio of 0.32, but the trial's own registry status reads Unknown, exposing a gap between published data and registry housekeeping.

Personalized DC vaccine hits safety bar in 11-patient glioblastoma trial

Sat, 04 Jul 2026 23:13:00 GMT

The phase 1b abstract shows median PFS of 16.2 months and no OS reached, but the safety-only design and n=11 leave efficacy unproven.

Roche adds third enicepatide Phase 3, this one testing China-only obesity data

Fri, 03 Jul 2026 17:11:44 GMT

The 300-patient trial joins two larger enicepatide studies already underway, deepening Roche's bet on its dual GLP-1/GIP agonist against Lilly, Novo and a crowded obesity field.

Imbioray's AML Cell Therapy Trial Slips 2 Years, 5 Months to July 2027

Fri, 03 Jul 2026 17:09:46 GMT

The Phase 1 IBR733 study in relapsed/refractory AML has 18 patients at one China site and no posted efficacy or safety data, leaving the delay itself as the only confirmed fact.

Staidson's C5a antibody STSA-1002 clears Phase 1 safety bar in China

Fri, 03 Jul 2026 05:17:00 GMT

Multiple IV doses up to 20 mg/kg suppressed free C5a through Day 56 in 26 healthy volunteers, but the model's 4.1% endpoint-met read reflects a PK/PD bar, not a China-to-Phase-2 efficacy signal.

ETER100 renal safety analysis clears combo of no added kidney toxicity

Thu, 02 Jul 2026 00:50:00 GMT

A secondary analysis of the Phase 3 ETER100 trial shows benmelstobart plus anlotinib matched sunitinib on renal injury measures, but the trial's PFS primary endpoint result remains undisclosed.

Akeso trial for cadonilimab in kidney cancer completes with enrollment cut 60% to 28

Thu, 02 Jul 2026 00:00:00 GMT

NCT05256472 finished with 28 patients, well below the 70 the sponsor had targeted, and no primary ORR data have been posted to reveal whether the shrunken cohort still answers the question.

GCAR1 CAR T cell holds one ASPS patient's disease stable for 3 months

Wed, 01 Jul 2026 23:43:00 GMT

A single-participant, post hoc interim look at a first-in-human trial shows GPNMB-targeted CAR T is tolerable and biologically active, not yet proof of efficacy.

Bimekizumab 3-year data show durable work-productivity gains in PsA, axSpA

Wed, 01 Jul 2026 21:03:00 GMT

The July 1 abstract reports Year 3 quality-of-life and work-impairment data, not a new pivotal endpoint, from patients who stayed on bimekizumab through open-label extensions of two approved Phase 3 programs.

HengRui's SHR-A1811 cuts progression risk 78% versus pyrotinib in HER2+ breast cancer

Wed, 01 Jul 2026 18:53:00 GMT

Interim HORIZON-Breast01 data show median PFS of 30.6 months versus 8.3 months, but the trial remains open and final results are not yet in.

Sonrotoclax hits 52.4% ORR in MCL, already backing an FDA accelerated approval

Wed, 01 Jul 2026 16:03:00 GMT

The Phase I/II abstract confirms the data behind BEQALZI's May 2026 approval, but PFS of 6.5 months trails the durability bar BeOne will need to defend at confirmatory review.

FDA approves Orca Bio's Tregzi after Precision-T cut chronic GVHD-free survival gap

Tue, 30 Jun 2026 23:13:00 GMT

The Phase 3 Precision-T trial showed 78% of Tregzi recipients free of chronic GVHD or death at 12 months versus 38% on standard transplant, and the FDA approved the cell therapy days ahead of its July 6 target date.

Vistagen's fasedienol misses PALISADE-4 goal; subgroup signal seen

Tue, 30 Jun 2026 12:00:00 GMT

The Phase 3 trial of intranasal fasedienol missed its primary anxiety-relief endpoint in social anxiety disorder, and Vistagen is now pointing to a post-hoc subgroup and a redesigned pathway.

FDA approves Arcutis's Zoryve cream for plaque psoriasis in children as young as 2

Mon, 29 Jun 2026 23:06:39 GMT

The approval, based on a 4-week pharmacokinetics and safety study, extends Zoryve's label below the age of 6 and marks the drug's seventh FDA nod in four years.

FDA grants full PMA approval to Artivion's AMDS aortic dissection device

Mon, 29 Jun 2026 11:00:00 GMT

The approval eliminates the humanitarian-exemption IRB requirement and rests on PERSEVERE data showing a 72% relative cut in 30-day mortality versus hemiarch repair alone.

Otsuka's centanafadine beats placebo on ADHD and anxiety in Phase 3b trial

Thu, 25 Jun 2026 12:00:00 GMT

The 315-patient study hit its primary endpoint in adults with ADHD and comorbid anxiety, adding a second symptom domain to the drug's evidence base weeks before its FDA decision.

Achieve gets CRL for cytisinicline over manufacturing, not efficacy or safety

Mon, 22 Jun 2026 12:30:00 GMT

The FDA cited third-party manufacturing and labeling issues, not the drug's clinical data, and Achieve plans to resubmit in Q4 2026 with a new manufacturing partner.

Definium's single-dose DT120 clears MDD Phase 3 with an 8.1-point MADRS edge

Mon, 22 Jun 2026 11:00:00 GMT

Emerge, the first of two pivotal Phase 3 studies for the 5-HT2A psychedelic, hit its primary endpoint with rapid, durable separation from placebo and no new safety signal.

FDA approves Bayer's Ambelvist, a lower-dose gadolinium MRI contrast agent

Mon, 15 Jun 2026 06:30:00 GMT

The approval rests on Phase 3 QUANTI data showing lesion visualization at 0.01 mmol/kg comparable to existing agents dosed at twice to five times the gadolinium load.

FDA approves Keytruda plus Welireg as first adjuvant regimen in kidney cancer

Fri, 12 Jun 2026 20:10:00 GMT

The combination cut recurrence or death risk by 28% versus Keytruda alone, the first HIF-2α and PD-1 combination to reach approval in earlier-stage clear cell renal cell carcinoma.

Praxis' vormatrigine misses main goal in POWER1 focal seizure trial

Mon, 01 Jun 2026 20:15:00 GMT

The Phase 2/3 study missed its primary seizure-frequency endpoint, but a secondary responder measure hit and the higher 30 mg dose showed more seizure reduction late in the trial.

Oculis's OCS-01 eye drop misses primary endpoint in DME despite thickness benefit

Fri, 29 May 2026 19:05:50 GMT

Both Phase 3 DIAMOND trials failed on visual acuity at week 52, and Oculis said it will not pursue an FDA filing for OCS-01 in diabetic macular edema.

MannKind wins FDA approval for Afrezza in children as young as 6

Fri, 29 May 2026 16:30:00 GMT

The approval, backed by the Phase 3 INHALE-1 trial, makes Afrezza the first inhaled mealtime insulin option for pediatric patients after a century of injection-based therapy.

Novartis's pelacarsen Lp(a) HORIZON outcome trial still awaits its readout past mid-2026 window

Wed, 25 Feb 2026 12:00:00 GMT

The Phase 3 cardiovascular outcomes trial closed enrollment years ago, but Novartis has not disclosed results after guiding to a mid-2026 readout, leaving the field's most advanced Lp(a)-lowering test still open.

CG Oncology's PIVOT-006 data slip past H1 2026 guidance

Fri, 09 Jan 2026 13:30:00 GMT

The Phase 3 readout in intermediate-risk bladder cancer has not posted despite four rounds of sponsor guidance for H1 2026, even as the trial's own completion date moved to November.

MoonLake's sonelokimab HS trials sit completed with 52-week data still unreleased

Wed, 05 Nov 2025 12:00:00 GMT

VELA-1 and VELA-2 finished in June 2026, but the 52-week HiSCR75 readout MoonLake guided to Q2 2026 has not been disclosed as that window closed.

FDA clears Unicycive's OLC for hyperphosphatemia after 2025 CRL

Thu, 14 Aug 2025 19:55:23 GMT

The FDA accepted Unicycive's resubmitted NDA and set a June 29, 2026 PDUFA date a year after a manufacturing-related complete response letter forced the restart.

Incretin obesity drugs spare muscle function despite mild lean-mass loss, study finds

Wed, 06 Aug 2025 05:15:00 GMT

A mouse-and-human analysis finds weight loss from incretin-based therapies comes mostly from fat and liver mass, with muscle-to-bodyweight ratio and strength relative to weight improving rather than declining.

Lilly's bimagrumab-semaglutide combo posted 17.8 kg weight loss at week 48

Fri, 18 Jul 2025 00:00:00 GMT

A completed Phase 2 trial found high-dose bimagrumab plus semaglutide 2.4 mg beat either drug alone on weight loss, with results now posted after the study closed in June 2025.

Lilly's bimagrumab-semaglutide combo posted a 17.8 kg weight loss at week 48

Fri, 18 Jul 2025 00:00:00 GMT

The Phase 2 obesity trial's posted results show high-dose bimagrumab plus semaglutide beat either drug alone, with results already public a year before this listing.

Botanical CL19183 cuts body weight and fat versus placebo in 16-week RCT

Mon, 14 Jul 2025 07:36:00 GMT

A randomized, placebo-controlled trial of the citrus-cacao extract combination Theolim showed greater weight loss, fat loss, and resting metabolic rate gains in overweight adults.

Viatris's second pivotal MR-142 eye drop trial data still pending past H1 2026 window

Mon, 02 Jun 2025 12:00:00 GMT

LYNX-3 must replicate LYNX-2's positive result to complete the pivotal package for a condition with no FDA-approved therapy.

Neumora's navacaprant Phase 3 completes with KOASTAL-2 data still unreported

Mon, 12 May 2025 20:01:00 GMT

The MDD trial finished and enrollment reset to 430, but topline results Neumora guided to Q2 2026 have not landed as a prior Phase 3 kappa antagonist for depression already failed.