Upcoming Data Readouts
376- PDUFA Date
Otsuka's centanafadine faces July 24 FDA decision for adult ADHD
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.
NCT03605680 - PDUFA Date
Otsuka's centanafadine faces July 24 FDA verdict after positive ADHD anxiety data
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.
NCT06973577 - PDUFA Date
Regeneron's garetosmab nears FDA verdict on 94% HO-lesion cut in FOP
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.
NCT05394116 - PDUFA Date
GSK's bepirovirsen heads to FDA decision on positive Phase 3 cure data
The October 26 PDUFA date tests whether two positive Phase 3 trials translate into the first approved functional-cure therapy for chronic hepatitis B.
NCT05630807 - PDUFA Date
Ultragenyx's DTX401 gene therapy faces FDA priority review verdict August 23
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.
NCT05139316 - Regulatory Approval
Ocugen's OCU400 heads toward a 2026 EMA filing decision in retinitis pigmentosa
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.
NCT06388200 - Status Change
Chia Tai Tianqing opens China trial testing adalimumab in pediatric uveitis
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.
NCT07663331 - Status Change
Karyopharm's decade-old selinexor myeloma trial re-opens enrollment for a new arm
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.
NCT02343042 - Status Change
M.D. Anderson prostate trial reopens enrollment after March closeout
The Nautilus lutetium trial swung from Active-not-recruiting back to Recruiting four months after cutting its enrollment target from 36 to 6.
NCT06066437 - Status Change
Chia Tai Tianqing opens China Phase 2 of JAK2 drug TQ05105 in myelofibrosis
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.
NCT07551427 - Trial Registered
SHY Therapeutics starts Phase 1 dose-finding trial of proteasome inhibitor SHY-ONC6
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.
NCT07705334 - Primary Completion Date Change
Endevica's cachexia trial pushes primary readout to October 2027, third delay
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.
NCT06937177 - Status Change
CSPC Ouyi opens dosing in Phase 1 trial of injectable pain drug SYH9089
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.
NCT07519109 - Trial Registered
Beijing Gene Key registers Phase 1 test of allogeneic cell therapy GKL-006Allo
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.
NCT07704515 - Trial Registered
FutureGen pairs two CLDN18.2 antibodies in new China -tumor trial
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.
NCT07704866 - Trial Registered
Suncadia tests TNF blocker adalimumab as adjunct in resectable lung cancer
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.
NCT07704645 - Status Change
Jiangsu HengRui starts Phase 3 KRAS G12D pancreatic cancer trial, only one of its kind
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.
NCT07232875 - Trial Registered
Shenzhen Core Medical opens 6-patient trial of percutaneous right-heart pump
The device-feasibility study will test whether CorVad can support patients in refractory right heart failure through explant, with survival as the primary measure.
NCT07704424 - Trial Registered
Vigonvita plans Phase 2 test of VV119 against PANSS in acute schizophrenia
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.
NCT07703956 - Trial Registered
Peg-Bio opens 8-patient Phase 2 test of FT1 in short bowel syndrome
The trial measures fecal wet weight against baseline in a metabolic balance study, entering a field where GLP-2 drugs already dominate.
NCT07704047 - NEGATIVE RESULTS
aTyr's efzofitimod misses again on steroids in sarcoidosis lung subgroup
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.
NCT05415137 - Conference Presentation
Profound Medical to present CAPTAIN safety data on TULSA vs. prostatectomy at SRS2026
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.
NCT05027477 - Conference Presentation
Profound Medical's CAPTAIN trial to present TULSA safety data vs prostatectomy
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.
NCT05027477 - Conference Presentation
Merck to present ISLEND-2 Week 48 data confirming weekly ISL/LEN met endpoint
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.
NCT06630299 - Conference Presentation
Merck to unveil Week 24 data on weekly islatravir/ulonivirine at AIDS 2026
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.
NCT06891066 - Conference Presentation
Gilead's weekly islatravir/lenacapavir met HIV suppression goal versus Biktarvy
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.
NCT06630286 - Data Readout
Veradermics to unveil Phase 2 female-arm data for oral minoxidil pill VDPHL01
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.
NCT06527365 - Conference Presentation
Annexon's ARCHER data will pick who enrolls in pivotal ARCHER II readout
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.
NCT04656561 - Conference Presentation
Alpha Tau to present full HNSCC data after 75% ORR interim readout
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.
NCT05047094 - Conference Presentation
Alkeus to present Phase 2 TEASE gildeuretinol data alongside Phase 3 design at ASRS
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.
NCT02402660 - Data Readout
Axsome's ENGAGE trial tests solriamfetol in binge eating disorder past a stale completion date
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.
NCT06413433 - Conference Presentation
Enterome's EO2463 vaccine posts 74% ORR in lymphoma combination cohort
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.
NCT04669171 - Data Readout
Eupraxia's EP-104GI heads toward Phase 2b EoE readout after early biopsy signal
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.
NCT05608681 - Enrollment Milestone
AIM's DURIPANC trial nears enrollment finish, primary readout due December
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.
NCT05927142 - Data Readout
MediciNova heads toward summer topline data for tipelukast in diabetic NAFLD
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.
NCT05464784 - First Patient Dosed
Curis sets up TakeAim CLL dosing by July, data due December 2026
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.
NCT07271667 - Data Readout
Celldex's prurigo nodularis data for barzolvolimab lands with itch-relief bar set at Week 12
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.
NCT06366750 - Data Readout
Kodiak's DAYBREAK trial nears wet AMD readout against Aflibercept
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.
NCT06556368 - Data Readout
Karyopharm's XPO1 maintenance trial in endometrial cancer nears its PFS readout
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.
NCT05611931 - Data Readout
Pharming widens leniolisib beyond APDS to broader PI3Kδ-driven PIDs in H2 2026 test
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.
NCT06549114 - Data Readout
Connect Biopharma's rademikibart faces asthma test after enrollment closes
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.
NCT06940141 - Data Readout
Acumen's sabirnetug Alzheimer's readout nears with amyloid class 3-for-3 in Phase 3
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.
NCT06335173 - Data Readout
BioVie's bezisterim faces first Phase 2 test as monotherapy in untreated Parkinson's
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.
NCT06757010 - Data Readout
NeOnc's NEO100 heads toward an interim readout in a glioma trial with no direct rival
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.
NCT02704858 - Data Readout
Invivyd's pivotal COVID prevention trial pushes readout into Q3 2026
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.
NCT07298434 - Data Readout
MediciNova heads toward H2-2026 ALSFRS-R data for ibudilast in ALS
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.
NCT04057898 - Data Readout
Incyte's povorcitinib asthma readout slips again as Phase 2 nears finish
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.
NCT05851443 - Data Readout
Nektar's rezpeg faces Q4 off-treatment readout after alopecia data already showed responses
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.
NCT06340360 - Conference Presentation
Nektar to present 36-week rezpegaldesleukin maintenance data in H2 2026
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.
NCT06136741 - Data Readout
Vera pulls forward ORIGIN 3 kidney-function readout for atacicept to Q3 2026
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.
NCT04716231 - PDUFA Date
Celcuity's gedatolisib faces July 17 FDA decision on 16.6-month PFS data
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.
NCT05501886 - Data Readout
Altimmune's pemvidutide faces Q3 alcohol-disorder readout after enrollment closed early
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.
NCT06987513 - Data Readout
Travere's HARMONY trial for HCU pushes primary completion 20 months to 2027
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.
NCT06247085 - Conference Presentation
REGENXBIO to present 2.5-year ALTITUDE gene therapy data as NAAVIGATE enrolls
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.
NCT04567550 - Data Readout
FDA tells Longeveron its HLHS trial's endpoint can't prove efficacy, mid-study
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.
NCT04925024 - Data Readout
Cloudbreak's CBT-001 nears Phase 3 pterygium data after Phase 2 hit both endpoints
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.
NCT05456425 - Conference Presentation
Ocugen to detail OCU410 gene therapy imaging and safety data at ASRS
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.
NCT06018558 - Data Readout
AtaiBeckley's DMT film for resistant depression heads to a Q4 readout
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.
NCT06524830 - Conference Presentation
Ollin presents head-to-head OLN324 vs. Vabysmo data at ASRS ahead of Phase 3
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.
NCT07484074 - Conference Presentation
Cognition's zervimesine slowed DLB hallucinations 89%, FDA calls it approvable
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.
NCT05225415 - Conference Presentation
Eisai brings AHEAD 3-45 retention data to AAIC, not efficacy results
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.
NCT04468659 - Conference Presentation
REGENXBIO to present five-year RGX-314 wet AMD gene therapy data in July
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.
NCT03066258 - AMBIGUOUS RESULTS
Codex Labs to present 95% SCORAD drop in open-label pediatric eczema pilot
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.
NCT07670676 - PDUFA Date
Viatris awaits July 30 FDA decision on low-dose estrogen contraceptive patch
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.
NCT05139121 - PDUFA Date
Moderna's mRNA-1010 flu shot heads to FDA on a 26.6% efficacy edge over standard vaccines
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.
NCT06602024 - Data Readout
Nocion's Phase 2b cough trial nears data after two completion-date pushes
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.
NCT06504446 - Conference Presentation
Nervonik to present nerve-sensing data from 8-patient study at ASPN 2026
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.
NCT06772142 - Data Readout
MapLight's ZEPHYR schizophrenia trial completes, results due by mid-August
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.
NCT07038876 - Conference Presentation
Acumen's AAIC poster is patient survey data, not ALTITUDE-AD topline results
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.
NCT06335173 - Conference Presentation
Organon to show pooled ADORING data on VTAMA in AD across pediatric, adult ages
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.
NCT05032859 - Conference Presentation
CervoMed posts first 80 mg neflamapimod data in Lewy body dementia
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.
NCT06815965 - Conference Presentation
NewAmsterdam extends obicetrapib's LDL story into an Alzheimer's biomarker signal
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.
NCT05142722 - Conference Presentation
Belite Bio's DRAGON data head to ASRS as first Phase 3 win in Stargardt disease
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.
NCT05244304 - Conference Presentation
NewAmsterdam extends obicetrapib's cardiovascular data into an Alzheimer's biomarker signal
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.
NCT05142722 - AMBIGUOUS RESULTS
Alzheon presses ALZ-801 case with 4-year data after Phase 3 miss
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.
NCT04693520 - Conference Presentation
Cognition Therapeutics to detail Phase 3 plan for CT1812 in DLB psychosis
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.
NCT05531656 - Conference Presentation
Nocion to detail ASPIRE cough trial status as Q3 readout nears
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.
NCT06504446 - Conference Presentation
Alkeus to detail Phase 3 gildeuretinol design for Stargardt disease at ASRS
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.
NCT07419334 - Conference Presentation
Mighty Therapeutics details FDA-mandated Phase 4 trial confirming elamipretide in Barth syndrome
The July 22 conference presentation covers a 48-patient confirmatory trial required after FORZINITY's accelerated approval, not a new efficacy readout.
NCT07531251 - Conference Presentation
Astellas to present GATHER1 driving-eligibility and EZ integrity data for IZERVAY at ASRS
New biomarker and functional analyses from the completed GATHER1 trial extend evidence behind the only approved complement inhibitor for geographic atrophy.
NCT02686658 - Conference Presentation
Astellas to unveil first Phase 1b look at stem cell therapy ASP7317 in GA
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.
NCT03178149 - Conference Presentation
Ollin details OLN324's head-to-head edge over faricimab in wAMD at ASRS
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.
NCT07484074 - Conference Presentation
Biogen to unveil first CELIA data on tau-targeting BIIB080 at AAIC
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.
NCT05399888 - Conference Presentation
Ocugen to detail 1-year OCU410 gene therapy data for geographic atrophy at ASRS
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.
NCT06018558 - Enrollment Change
AstraZeneca expands ARTEMIDE-Lung02 to 1,160 patients, extends completion to 2030
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.
NCT06692738 - Enrollment Change
AstraZeneca expands Rilvegostomig lung cancer trial to 1,160 patients
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.
NCT06627647 - Trial Registered
Akeso registers Phase 3 test of cadonilimab against nivolumab in gastric cancer
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.
NCT07700979 - Trial Registered
CSPC Megalith opens Phase 2 test of therapeutic HPV vaccine for cervical lesions
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.
NCT07702656 - Trial Registered
Gubra registers first-in-human trial for obesity peptide GUB-UCN2
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.
NCT07702890 - Status Change
Vigonvita opens enrollment in Phase 1 food-effect study of VV913 capsules
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.
NCT07565792 - Status Change
Boehringer completes enrollment in nerandomilast-pirfenidone interaction study
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.
NCT06241560 - Status Change
Nexcella's NXC-201 trial stops enrolling after a 95% response rate in AL amyloidosis
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.
NCT06097832 - Status Change
Vigonvita opens dosing in early Phase 1 study of oral VV913 in China
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.
NCT07507838 - Trial Registered
Hengrui tests autoinjector for SHR-1703 in a bridging pharmacokinetics study
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.
NCT07701239 - Status Change
Multitude Therapeutics opens dosing in AMT-116 lung cancer combination with Ivonescimab
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.
NCT07590531 - Trial Registered
Kelun-Biotech to test B7-H3 ADC plus PD-1 blocker in esophageal cancer
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.
NCT07700667 - Trial Registered
GSK tests depemokimab alone, without steroids, for nasal polyps in Japan
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.
NCT07701967 - Status Change
Innovent opens dosing in Phase 1 trial of TED antibody IBI3031
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.
NCT07622368 - Status Change
AstraZeneca closes enrollment in Phase 2 test of eplontersen plus ALXN2220 combo
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.
NCT07608354 - Trial Registered
Peg-Bio starts Phase 1 dose-escalation trial of PA5 in advanced tumors
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.
NCT07702162 - Status Change
Akeso starts dosing AK146D1-AK112 combination in advanced NSCLC
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.
NCT07669779 - Conference Presentation
SPR to present 12-month RESET trial results for SPRINT PNS in back pain
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.
NCT04246281 - Conference Presentation
Kura to show longer follow-up on darlifarnib-cabozantinib in kidney cancer
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.
NCT06026410 - PDUFA Date
Elevar's lirafugratinib faces Sept. 27 FDA decision on 46.5% ORR in bile duct cancer
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.
NCT04526106 - PDUFA Date
Nuvalent's zidesamtinib nears Sept. 18 FDA decision on breakthrough-tagged ROS1 NSCLC drug
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.
NCT05118789 - PDUFA Date
Mirum's zilurgisertib nears Sept. 26 FDA verdict as first ALK2 drug for FOP
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.
NCT05090891 - PDUFA Date
FDA priority review sets Aug. 27 decision on Gilead's BIC/LEN switch pill
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.
NCT05502341 - Regulatory Designation
Agios awaits FDA filing verdict on mitapivat after mixed RISE UP results
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.
NCT05031780 - Regulatory Approval
Etripamil awaits NMPA verdict in China after already winning FDA nod
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.
NCT03464019 - PDUFA Date
Praxis faces Sept. 27 FDA decision on relutrigine while its own trial still enrolls
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.
NCT07010471 - Data Readout
Eupraxia's EP-104GI faces H2 2026 test after early EoE injections showed 65% EREFS gains
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.
NCT05608681 - Data Readout
NeOnc's NEO100 nears 2026 glioma data after nine-year, six-slip delay
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.
NCT02704858 - PDUFA Date
BMS's Camzyos hits Week 28 goal in teens, sets up Sept. 30 FDA call
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.
NCT06253221 - Data Readout
Inventiva's NATiV3 completion date slips 43 months, pushing lanifibranor readout to late 2027
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.
NCT04849728 - PDUFA Date
Inhibrx's DR5 antibody ozekibart heads to FDA review after halving progression risk
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.
NCT04950075 - Data Readout
Coya's ALSTARS trial to test whether Treg biologic slows ALS decline
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.
NCT07161999 - PDUFA Date
Apnimed's AD109 heads to FDA review after 55.6% AHI drop in sleep apnea trial
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.
NCT05813275 - Regulatory Approval
Nxera's daridorexant hits sTST goal in South Korea Phase 3, eyes 2027 nod
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.
NCT07028697 - Regulatory Approval
Everest Medicines takes China rights to LENZ's approved presbyopia drop VIZZ
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.
NCT06045299 - Data Readout
Lexicon's SONATA-HCM heads to Q1 2027 with no HCM drug yet SGLT-class approved
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.
NCT06481891 - Regulatory Approval
Savara's inhaled GM-CSF nears an EU verdict backed by a positive Phase 3 DLCO result
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.
NCT04544293 - Data Readout
Amplexd sets Q1 2027 readout for EGCg suppository in HPV cervical lesions
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.
NCT07572396 - Data Readout
CervoMed sets up nfvPPA data test for neflamapimod as DLB partnering takes priority
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.
NCT07033481 - Data Readout
Quince's inhaled sirolimus faces a lonely BOS test as Q1 2027 data near
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.
NCT06018766 - Data Readout
Arcutis-linked roflumilast foam faces a 10-patient HS test with no active comparator
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.
NCT07077902 - Data Readout
Calluna's AURORA trial for CAL101 in IPF nears Q1 2027 lung-function data
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.
NCT06736990 - Data Readout
Veru sets Q1 2027 interim look at enobosarm's bid to beat GLP-1 weight-loss plateau
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.
NCT07446998 - PDUFA Date
FDA to decide on zipalertinib for EGFR exon 20 NSCLC by Feb. 27, 2027
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.
NCT04036682 - PDUFA Date
Gilead's weekly oral lenacapavir PrEP pill faces FDA decision Feb. 2, 2027
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.
NCT04925752 - Data Readout
Climb Bio's budoprutug already showed 90% B-cell depletion in ITP before H2 data
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.
NCT07043946 - Data Readout
Dyne's ACHIEVE trial for DM1 heads to a Q1 2027 readout after full enrollment
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.
NCT05481879 - Data Readout
Astria's navenibart Phase 3 in HAE heads toward a 2026 readout
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.
NCT06842823 - Data Readout
Pacira's ZILRETTA shoulder OA trial nears readout after enrollment closed
The Phase 3 study finished enrollment in April 2026 and could make ZILRETTA the first approved treatment specifically labeled for shoulder osteoarthritis pain.
NCT06269705 - Conference Presentation
Cabaletta's rese-cel gMG data due in H2 2026, months after AAN preview
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.
NCT06359041 - Data Readout
Insmed's open-label TPIP extension in PAH tests durability, not a new efficacy bar
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.
NCT05649748 - Data Readout
Cartesian's Descartes-08 heads to Phase 3 MG readout as only such trial in class
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.
NCT06799247 - Data Readout
Aktis targets Q1 2027 dose-finding readout for Nectin-4 radioconjugate AKY-1189
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.
NCT07020117 - Conference Presentation
Immunocore heads toward H2 2026 dose data on second PRAME bispecific
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.
NCT07156136 - Data Readout
Immunocore's second PRAME cell therapy heads to a safety readout in H2 2026
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.
NCT07156136 - Regulatory Submission
DBV plans BLA for peanut patch in toddlers as safety trial keeps enrolling
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.
NCT07003919 - Regulatory Submission
ImPact's Padeliporfin hits 70% complete-response rate ahead of planned 2026 NDA
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.
NCT04620239 - Data Readout
DBV's Viaskin peanut patch safety study in toddlers nears its readout
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.
NCT07003919 - Data Readout
Beacon's laru-zova gene therapy nears pivotal XLRP readout
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.
NCT04850118 - Regulatory Approval
Rhythm's setmelanotide awaits Japan verdict after US and EU nods in hypothalamic obesity
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.
NCT05774756 - Data Readout
Arrowhead's ARO-MAPT tau data due H2 2026 in a field with no approved tau drug
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.
NCT07221344 - Data Readout
CG Oncology's cretostimogene combo hits 96% early bladder cancer control
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.
NCT06567743 - Data Readout
Immatics' Phase 3 melanoma cell therapy trial heads toward 2026 readout
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.
NCT06743126 - Data Readout
Acadia's ACP-204 psychosis trial still recruiting as guided readout window opens
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.
NCT06159673 - Regulatory Submission
BioCardia targets Japan PMDA filing for CardiAMP after years of trial delay
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.
NCT02438306 - Regulatory Approval
MaaT013 awaits EMA verdict after 62% GI response rate in ARES trial
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.
NCT04769895 - Conference Presentation
Compass sets up full COMPANION-002 data unveil after tovecimig hit ORR, PFS
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.
NCT05506943 - Data Readout
Relmada readies Phase 3 NDV-01 bladder cancer trial after 95% Phase 2 CR rate
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.
NCT07464145 - Data Readout
SeaStar's NEUTRALIZE-AKI trial grows to 339 patients, pushes readout to 2026
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.
NCT05758077 - MIXED
Dynavax's Z-1018 heads into head-to-head shingles data versus Shingrix
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.
NCT06569823 - Regulatory Approval
Ionis targets a 2026 launch for zilganersen, its first neurology drug filing
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.
NCT04849741 - Data Readout
Evommune's oral EVO756 heads to a Phase 2b eczema readout in H2 2026
The 120-patient trial tests whether blocking MRGPRX2, a target with no approved drug in atopic dermatitis, can move EASI scores against placebo.
NCT07150845 - Data Readout
Kodiak's KSI-101 heads to Phase 3 readout after Phase 1b BCVA and drying data
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.
NCT06990399 - Regulatory Submission
Ocular Therapeutix plans AXPAXLI wet AMD NDA on SOL-1 data, not SOL-R efficacy
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.
NCT06495918 - Data Readout
Perspective's VMT01 melanoma readout will test early signal of 2 of 7 responses
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.
NCT05655312 - Data Readout
Spyre's SPY072 basket trial heads toward three-indication readout in Q4 2026
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.
NCT07148414 - Data Readout
Immatics readies IMA402 dose and Phase 1 data for melanoma, ovarian tumors
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.
NCT05958121 - PDUFA Date
PolyPid's D-PLEX100 heads to FDA review with a PDUFA date near Q1 2027
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.
NCT04411199 - Regulatory Submission
Cerus's ReCePI trial met its AKI non-inferiority bar ahead of 2026 FDA filing
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.
NCT03459287 - Data Readout
Vivani's semaglutide implant faces its first human PK test by year-end
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.
NCT07430059 - Regulatory Submission
Cerus nears FDA filing for RedeS red-cell trial after 692-patient enrollment closes
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.
NCT03037164 - Data Readout
Cerus's RedeS Phase 3 nears results after enrollment closed on schedule
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.
NCT03037164 - Data Readout
Ocugen's OCU400 Phase 3 in retinitis pigmentosa nears topline data, enrollment closed
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.
NCT06388200 - Data Readout
Alnylam's ALN-HTT02 heads to H2 2026 safety readout in Huntington's
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.
NCT06585449 - Regulatory Submission
Iovance's NSCLC filing hinges on IOV-LUN-202 data still to come in 2026
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.
NCT04614103 - Data Readout
Kelun-Biotech readies first human data for its ITGB6-targeted ADC SKB105
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.
NCT07380386 - Data Readout
Alpha Tau widens pancreatic cancer trial to test alpha radiation with more chemo regimens
Alpha Tau expanded the IMPACT trial's chemotherapy backbone and raised enrollment to 40 as it targets initial safety results by year-end 2026.
NCT06698458 - Data Readout
Immix's NXC-201 posts 95% CR rate in AL amyloidosis ahead of March 2027 update
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.
NCT06097832 - Data Readout
BioRestorative completes BRTX-100 enrollment, sets up 2027 spine trial readout
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.
NCT04042844 - Enrollment Milestone
Immatics' SUPRAME trial advances toward 2026 enrollment completion in melanoma
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.
NCT06743126 - Material Event
NextCure pushes LNCB74 -tumor data to H2 2026 as enrollment lags
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.
NCT06774963 - Data Readout
Transgene's TG4050 heads toward first Phase II immune data in H2 2026
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.
NCT04183166 - Data Readout
Barinthus Bio's celiac vaccine faces H2 2026 safety readout for AVALON
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.
NCT06310291 - Data Readout
Zealand's ZP9830 SAD data clear safety bar; MAD readout due H2 2026
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.
NCT06682975 - Conference Presentation
Tenaya to present two-year TN-201 gene therapy data in HCM in H2 2026
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.
NCT05836259 - Data Readout
BioLineRx's GLIX1 dose-escalation trial in glioma advances toward first human data
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.
NCT07464925 - Data Readout
Kodiak's Phase 3 PINNACLE for KSI-101 targets BCVA gains in Q1 2027
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.
NCT06996080 - Data Readout
Tectonic's TX45 heads to Q1 2027 readout after full enrollment in PH-HFpEF
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.
NCT06616974 - Data Readout
Alnylam's RNAi obesity drug ALN-2232 heads toward first human weight-loss data
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.
NCT07463846 - Data Readout
Zai Lab's DLL3 ADC zoci nears first combo readout in frontline SCLC
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.
NCT06179069 - Data Readout
BioAtla's BA3182 tests durability as expansion-phase data near in H2 2026
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.
NCT05808634 - Data Readout
Agomab's ontunisertib extension data due H2 2026 will test durability in Crohn's
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.
NCT05843578 - First Patient Dosed
Cenna's 8M2D targets amyloid production, not clearance, in first human test
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.
NCT07568041 - Data Readout
Plus Therapeutics eyes Q1 2027 data for radiopharmaceutical in recurrent glioma
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.
NCT01906385 - Data Readout
Therini Bio's THN391 heads toward first human data in DME this quarter
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.
NCT06701721 - Data Readout
PepGen's low-dose DM1 cohort missed on function; next dose is the test
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.
NCT06667453 - Regulatory Approval
Adagio's vCLAS posts 59% VT-free rate at 6 months ahead of PMA decision
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.
NCT05675865 - Data Readout
Adicet's prula-cel faces systemic sclerosis test in a Phase 1 safety cohort
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.
NCT06375993 - Conference Presentation
Biogen to detail salanersen Phase 1b data as Phase 3 program advances behind it
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.
NCT05575011 - Data Readout
Fractyl's Revita device faces pivotal weight-maintenance test this Q4
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.
NCT06484114 - Regulatory Approval
Edwards awaits FDA call on PASCAL for tricuspid regurgitation as pivotal trial keeps enrolling
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.
NCT04097145 - Regulatory Approval
IceCure asks Health Canada to widen ProSense cryoablation to older women
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.
NCT02200705 - Data Readout
Oragenics eyes Q4 2026 readout for ONP-002 in mTBI, a trial not yet enrolling
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.
NCT06870240 - Data Readout
Vanda's second Phase 3 test of milsaperidone in depression targets Q1 2027
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.
NCT06830044 - Data Readout
Dianthus keeps Q4 2026 target for DNTH103 trial in rare nerve disease
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.
NCT06537999 - Data Readout
Aclaris heads toward H2 2026 Phase 2 readout for TSLP drug bosakitug in eczema
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.
NCT07011706 - Data Readout
Dianthus clears CIDP interim GO gate; Part B relapse data due by year-end
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.
NCT06858579 - Regulatory Submission
Terumo readies Japan filing for IceCure's breast-cancer cryoablation device
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.
NCT02200705 - Data Readout
BioVersys plans BV100 interim readout as its Phase 3 program runs in parallel
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.
NCT07431307 - Data Readout
Atisama's inhaled RB042 heads toward higher-dose Phase 1 safety readouts
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.
NCT07285122 - Data Readout
Agomab awaits first IPF patient data on inhaled AGMB-447 in late 2026
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.
NCT06181370 - Enrollment Milestone
60 Degrees reports all three babesiosis patients cured with tafenoquine regimen
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.
NCT06478641 - Data Readout
AdipoPharma's PATAS heads toward first human safety data by year-end
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.
NCT07223333 - Data Readout
Akebia's AKB-9090 begins dosing in Phase 1 trial testing kidney-injury biomarkers
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.
NCT07429006 - Data Readout
4DMT's 4D-150 heads toward 2-year DME data after 86% injection cut at 32 weeks
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.
NCT05930561 - Data Readout
Aligos targets 2026 for first interim data on HBV pill ALG-000184
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.
NCT04746183 - Data Readout
NovaBridge's ragistomig posts Q6W safety edge ahead of H2 2026 Phase 1 readout
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.
NCT04762641 - Data Readout
Dogwood's Halneuron heads toward Phase 2b pain data with no direct rival
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.
NCT06848348 - Data Readout
MetaVia's DA-1726 heads toward Q4 data testing higher-dose tolerability
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.
NCT06252220 - Data Readout
Alnylam's ALN-6400 heads toward first human safety data in HHT this year
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.
NCT06659640 - Data Readout
AtaiBeckley eyes Q4 data from BPL-003's two-dose TRD cohort as Phase 3 launches
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.
NCT05660642 - Regulatory Submission
XVIVO to file heart-preservation device for FDA approval after PRESERVE trial hit
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.
NCT05881278 - Material Event
Rigel targets H2 2026 Phase 2 dose pick for R289 after 33% RBC-TI signal
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.
NCT05308264 - Data Readout
Monte Rosa's MRT-8102 faces H2 test to confirm 85% CRP cut in more patients
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.
NCT07119125 - AMBIGUOUS RESULTS
Zai Lab's ZL-1503 heads to H2 2026 safety readout in atopic dermatitis
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.
NCT07235384 - Data Readout
Cybin's CYB003 heads to Q4 2026 MDD readout after guiding six times
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.
NCT06564818 - Data Readout
Krystal's inhaled gene therapy for CF heads toward a 2026 Phase 1 readout
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.
NCT05504837 - Data Readout
Imbria's ninerafaxstat heads toward FORTITUDE-HCM data with no rival on its mechanism
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.
NCT07023614 - Data Readout
Glycomine's GLM101 nears first placebo-controlled test in PMM2-CDG
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.
NCT06892288 - Data Readout
Agios targets H2 2026 proof-of-mechanism readout for oral PKU drug AG-181
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.
NCT07241234 - Data Readout
CRISPR's FXI siRNA CTX611 heads toward H2 2026 data versus enoxaparin in TKA
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.
NCT07140523 - Enrollment Milestone
Alpha Tau's implanted-seed trial in recurrent GBM targets enrollment finish by H2 2026
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.
NCT06910306 - Data Readout
Alpha Tau's GBM device trial heads to a small feasibility readout in Q4 2026
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.
NCT06910306 - Data Readout
Bambusa's BBT002 heads toward a safety readout in COPD patients by year-end
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.
NCT07288554 - Data Readout
Alto's ALTO-300 targets a biomarker-defined MDD subgroup in Phase 2b test
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.
NCT05922878 - Data Readout
NextCure's LNCB74 dose-escalation update tests a B7-H4 ADC facing GSK, AstraZeneca
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.
NCT06774963 - Data Readout
Azitra's ATR-04 rash trial pushes toward a first-cohort readout in H2 2026
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.
NCT06830863 - Data Readout
Protara's THRIVE-3 heads toward H2 2026 readout with no rival IV choline trial
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.
NCT06910943 - Data Readout
Nanjing Leads Biolabs sets up Phase 1 safety readout for dual-target lupus drug LBL-047
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.
NCT07323173 - Data Readout
Disc Medicine's DISC-0974 heads to Q4 topline after ASCO data on 61 patients
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.
NCT05320198 - Regulatory Submission
Avidity's del-brax BLA plan hinges on FORTITUDE biomarker data, not this OLE trial
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.
NCT06547216 - Data Readout
Rigel targets 2026 R289 dose-expansion data after 33% transfusion independence
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.
NCT05308264 - Data Readout
Sionna's SION-451 combination trial heads to a safety readout this half
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.
NCT07035990 - Data Readout
Apogee's safety trial of APG777+APG990 vs Dupixent nears H2 2026 readout
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.
NCT07027527 - Data Readout
Edwards' RESILIA tissue posts 97.9% freedom from valve deterioration at 10 years
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.
NCT01757665 - Data Readout
Septerna's oral PTH1R drug SEP-479 heads into Phase 1 readout for hypoparathyroidism
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.
NCT07433179 - Data Readout
NuCana's NUC-7738 melanoma data due in H2 2026 after early partial responses
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.
NCT03829254 - Data Readout
Treace's ALIGN3D bunion study heads toward 5-year data in 2026
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.
NCT03740282 - Data Readout
60 Degrees eyes H2 2026 tafenoquine data as its babesiosis sNDA basis
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.
NCT06656351 - Data Readout
Tectonic's TX45 heads to PH-HFpEF data test with no validated mechanism in the field
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.
NCT06616974 - Data Readout
Annexon's ARCHER II Sets Up Q4 Test of Vision Loss, Not Growth
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.
NCT06510816 - Data Readout
Design Therapeutics builds on DT-216P2 frataxin gains ahead of H2 2026 update
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.
NCT06874010 - Data Readout
Vanda pushes Bysanti MDD trial readout to Q1 2027, a year past guidance
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.
NCT06830044 - Data Readout
Alto's ALTO-100 bipolar depression trial tests a fix for its 2024 MDD miss
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.
NCT06656416 - Data Readout
Oruka's ORKA-001 hits 63.5% skin clearance; durability data due in H2
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.
NCT07090330 - Conference Presentation
Apogee's asthma antibody already showed FeNO cuts; more data due in H2
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.
NCT06920901 - Data Readout
Lantern's LP-300 posts 8.3-month PFS signal in 16 EGFR L858R patients
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.
NCT05456256 - Data Readout
Satellos moves BASECAMP DMD readout timeline as trial keeps enrolling
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.
NCT07287189 - Data Readout
Ultragenyx's pivotal Angelman syndrome trial nears its only readout window
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.
NCT06617429 - Data Readout
Disc Medicine's DISC-3405 heads to Q4 2026 PV data with no rival in human testing
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.
NCT06985147 - Data Readout
Moderna's mRESVIA revaccination data show durable immune response in adults 60+
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.
NCT07117487 - Data Readout
Biomea's Phase 1 oral GLP-1 BMF-650 nears first weight-loss data
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.
NCT07223216 - Data Readout
Absci's ABS-201 posts clean SAD safety data ahead of H2 2026 efficacy readout
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.
NCT07317544 - PDUFA Date
Vertex's povetacicept BLA in IgA nephropathy carries a positive Week 36 result into FDA review
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.
NCT06564142 - Data Readout
Vertex targets H2 2026 for first VX-670 muscle-biopsy data in DM1
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.
NCT06185764 - Regulatory Submission
MoonLake to file HS drug on data with a missed Phase 3 endpoint
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.
NCT06411379 - Data Readout
Kiniksa's KPL-387 heads toward first pericarditis data with no IL-1R1 rival
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.
NCT07010159 - Data Readout
Zura Bio's dual BAFF/IL-17A antibody heads toward Phase 2 HS readout
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.
NCT06993610 - Data Readout
Alumis heads toward Q3 2026 LUMUS readout for oral TYK2 drug in lupus
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.
NCT05966480 - Regulatory Submission
Moderna's mRNA-1010 flu vaccine heads toward 2026 filings beyond the US
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.
NCT06602024 - Regulatory Approval
Moderna's mRNA-1010 flu shot clears FDA and Health Canada review acceptance
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.
NCT06602024 - Data Readout
Neumora's NMRA-511 posts 0.34-effect size ahead of H2 2026 dose-finding data
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.
NCT06546995 - Data Readout
Biohaven's opakalim epilepsy trial nears H2 2026 readout after two delays
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.
NCT06309966 - PDUFA Date
Viatris awaits Dec. 27 FDA verdict on non-opioid pain drug meloxicam-107A-02
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.
NCT06215820 - Data Readout
Spyre's SPY003 data will test if SKYLINE's IL-23 arm repeats SPY001's RHI win
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.
NCT07012395 - Data Readout
Incyte's early-stage JAK2V617F drug faces H2-2026 safety readout
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.
NCT06313593 - Regulatory Submission
Traws Pharma resubmits TXM safety data to MHRA to unlock flu challenge trial
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.
NCT07503405 - Data Readout
Ascletis moves ASC30 into diabetes as Phase 2 readout nears in Q3 2026
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.
NCT07321678 - Data Readout
Praxis heads toward H2 2026 elsunersen readout in SCN2A epilepsy
EMBRAVE3 will test whether elsunersen cuts seizure frequency in infants with early-seizure-onset SCN2A DEE, a disease with no approved disease-modifying treatment.
NCT07019922 - Data Readout
Rapport pulls forward RAP-219 bipolar mania readout to Q4 2026
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.
NCT07046494 - Data Readout
Janux plans first JANX011 safety update in healthy volunteers by year-end
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.
NCT07291323 - PDUFA Date
FDA priority review sets Sept. 19 decision on AQNEURSA for A-T
IntraBio's supplemental filing seeks the first approved therapy for ataxia-telangiectasia, built on a 17-patient trial that later terminated after results posted.
NCT03759678 - PDUFA Date
IntraBio's AQNEURSA nears FDA verdict as first drug for A-T
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.
NCT06673056 - Conference Presentation
Leads Biolabs to present LBL-024 first-line NSCLC cohort data in September
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.
NCT06783647 - Data Readout
Rapport's RAP-219 long-term study feeds Phase 3 bet after 77.8% seizure cut
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.
NCT07219407 - Data Readout
Aardvark's HERO trial for ARD-101 in PWS is suspended, completion slips a year
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.
NCT06828861 - Data Readout
Adicet's ADI-001 RA update tests cell therapy without conditioning
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.
NCT07100873 - Data Readout
Biohaven's pivotal epilepsy trial for opakalim heads toward H2 2026 readout
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.
NCT06132893 - Material Event
Aligos' hepatitis B pill clears first futility check, DSMB expands cohort
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.
NCT06963710 - Data Readout
Candel's biomarker study backs up its Phase 3 prostate cancer data, not the trial itself
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.
NCT07332000 - Data Readout
Inmagene's IMG-007 atopic dermatitis trial pushes readout into 2027
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.
NCT07037901 - Data Readout
Triveni Bio's TRIV-509 heads to Phase 2 atopic dermatitis data in Q4 2026
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.
NCT07167758 - Data Readout
Vistagen's fasedienol repeat-dose trial nears a Q3 2026 SAD readout
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.
NCT06809179 - Data Readout
Cullinan's CLN-978 heads toward first RA repeat-dosing data in Q3
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.
NCT06994143 - PDUFA Date
FDA priority review sets up Q3 verdict on rusfertide for polycythemia vera
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.
NCT04057040 - Material Event
AIM's DURIPANC trial nears full Ampligen dosing as pancreatic cancer readout builds
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.
NCT05927142 - PDUFA Date
FDA priority review of Jazz's Ziihera in first-line gastric cancer nears Aug. 25 decision
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.
NCT05152147 - Data Readout
Sitryx completes enrollment early in Phase 1b oral PKM2 drug for eczema
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.
NCT07558668 - Regulatory Submission
argenx moves toward oMG label after VYVGART beats placebo in ADAPT OCULUS
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.
NCT06558279 - Data Readout
Vedanta's VE303 Phase 3 cleared its first futility check; a second test looms
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.
NCT06237452 - Data Readout
Celldex's CDX-622 heads to Q3 data after early doses cut tryptase 50%
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.
NCT06650761 - Conference Presentation
4DMT to show 4D-150's two-year wet AMD data ahead of pivotal readouts
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.
NCT05197270 - Data Readout
Profound's CAPTAIN trial heads toward a 2026 readout on TULSA vs. surgery
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.
NCT05027477 - Data Readout
Structure Therapeutics' aleniglipron extension data due after 16.2% interim win
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.
NCT06693843 - Data Readout
MBX Biosciences' obesity peptide posts 7% weight loss at 8 weeks in early look
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.
NCT07142707 - Data Readout
Immutep's IMP761 healthy-volunteer trial pushes MAD readout to Q3 2026
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.
NCT06637865 - PDUFA Date
FDA reviews WINREVAIR label expansion off HYPERION's worsening-event data
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.
NCT04811092 - PDUFA Date
Scholar Rock's apitegromab faces Sept. 30 FDA decision on SMA muscle drug
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.
NCT05156320 - Regulatory Submission
uniQure to file AMT-130 BLA in Huntington's on accelerated-approval path
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.
NCT04120493 - Data Readout
Disc Medicine's TMPRSS6 antibody heads toward first sickle cell safety data
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.
NCT07187973 - Regulatory Submission
BioMarin's VOXZOGO hits growth-velocity target in hypochondroplasia trial
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.
NCT06455059 - AMBIGUOUS RESULTS
Clene plans ALS accelerated-approval NDA built on a biomarker, not survival data
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.
NCT04098406 - Conference Presentation
Immunome to detail RINGSIDE's 84% progression-risk cut for varegacestat at ASCO
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.
NCT04871282 - Regulatory Submission
REGENXBIO clears dosing hurdle, sets up Q3 BLA for DMD gene therapy RGX-202
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.
NCT05693142 - Data Readout
Teva's IL-15 antibody nears celiac Phase 2a readout with enrollment complete
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.
NCT06807463 - Data Readout
Rein Therapeutics' LTI-03 IPF safety data due as trial re-enrolls after FDA hold
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.
NCT06968845 - Conference Presentation
Immix's NXC-201 hits 95% complete response rate ahead of September update
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.
NCT06097832 - Data Readout
Bolt delays BDC-4182 gastric cancer data to Q3 2026 for step-up dosing fix
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.
NCT06921837 - Data Readout
Spyre's SPY072 nears first RA data for an anti-TL1A antibody in Q3 2026
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.
NCT07148414 - Conference Presentation
SonoClear device data on tumor-margin imaging head to EANS in October
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.
NCT04734444 - Regulatory Submission
Cellectar targets Q3 2026 EU filing for iopofosine I 131 in Waldenstrom's
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.
NCT02952508 - Data Readout
Fractyl's Revita faces its first randomized weight-maintenance test in Q3
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.
NCT06484114 - Data Readout
Candel to unveil biomarker data from Phase 3 prostate gene therapy in Q3
The readout follows extended survival follow-up already promised for aglatimagene besadenovec, with a BLA submission planned before any of that data is public.
NCT01436968 - Data Readout
AbCellera heads toward Q3 readout for first-in-class menopause antibody
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.
NCT07118891 - Data Readout
Ocugen's OCU410ST gene therapy nears Stargardt interim readout with no rival past Phase 2
The Q3 2026 GARDian3 interim data will test a subretinal gene therapy that stands alone in advanced clinical testing for ABCA4-linked Stargardt disease.
NCT05956626 - Data Readout
NorthSea's orziloben nears Q3 readout in rare liver disease IFALD
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.
NCT05919680 - PDUFA Date
PharmaEssentia's BESREMi faces Aug. 30 FDA decision in essential thrombocythemia
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.
NCT04285086 - PDUFA Date
Telix's PET imaging agent TLX101-Px faces Sept. 11 FDA decision for glioma
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.
NCT06743100 - PDUFA Date
FDA to decide on Ionis's zilganersen for Alexander disease by Sept. 22
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.
NCT04849741 - Data Readout
Travere's HARMONY Restarts After 20-Month Delay, Reads Out H2 2027
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.
NCT06247085 - Data Readout
Vaxart's Oral COVID Vaccine Faces First Efficacy Test Against mRNA Shot in 2027
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%.
NCT06672055 - Data Readout
Nektar's Rezpeg Faces a Durability Test as Off-Treatment Data Loom in Q1 2027
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.
NCT06136741 - Data Readout
MannKind's inhaled nintedanib clears Cohort 1 safely, awaits IPF efficacy data
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.
NCT07344558 - Data Readout
ProMIS's PMN310 clears to top dose in Alzheimer's trial with no drug-related SAEs so far
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.
NCT06750432 - Data Readout
Genelux's OnPrime ovarian cancer trial slips again, pushing PFS data to late 2026
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.
NCT05281471 - Data Readout
Kyverna's one-year SPS data will test if 46% T25FW gain at 16 weeks holds up
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.
NCT06588491 - Data Readout
Axsome pushes SUSTAIN shift-work-disorder readout guidance from 2026 to 2027
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.
NCT06568367 - Data Readout
Connect Biopharma's rademikibart COPD readout faces model coin-flip on treatment failure rate
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.
NCT06940154 - Data Readout
Vaxart's oral COVID pill faces efficacy readout after 16-month completion date slip
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.
NCT06672055 - Data Readout
Harmony's Dravet Trial Hits Year Seven With Completion Pushed to 2027
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.
NCT04462770 - Data Readout
PALIZADE Data Already Show 42% CRR Rate Before Kezar's Terminated Trial Closes Out
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%.
NCT05781750 - Data Readout
Exelixis's STELLAR-304 Faces a Fourth Slip Before H2-2026 RCC Readout
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.
NCT05678673 - Data Readout
Karyopharm's Selinexor Trial Cuts Enrollment 58% Ahead of H2 2026 Readout
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.
NCT05028348 - MIXED
Axsome's SUSTAIN Readout Slips to 2027 as Sunosi Franchise Awaits Successor Data
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.
NCT06568367 - Data Readout
Vera's atacicept already hit its Phase 3 bar; 2027 readout tests durability
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.
NCT04716231 - Data Readout
ProMIS's PMN310 heads toward 2027 readout after full, on-time AD enrollment
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.
NCT06750432 - Data Readout
Harmony's ARGUS Dravet Trial Enrolls to 150 After Six-Year Slip to 2027
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.
NCT04462770 - Conference Presentation
Nanoscope to show 3-year MCO-010 data as BLA sits with FDA
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.
NCT04945772 - Trial Registered
Voronoi opens Phase 1/2 trial testing oral EGFR drug against C797S resistance
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.
NCT07699328 - Trial Registered
Chia Tai Tianqing registers dose-finding trial of TQB3126 in breast cancer
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.
NCT07697443 - Trial Registered
BioNTech registers Phase 1 HIV vaccine trial with an analytical treatment interruption
BNT168 will be tested in people with and without HIV, including a supervised pause in antiretroviral therapy to gauge immune control of the virus.
NCT07698600 - Status Change
Chengdu Suncadia opens dosing in first-in-human trial of HRS-1635 in B-cell cancers
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.
NCT07583212 - Trial Registered
AnHorn Medicines starts first human dosing of AH-008, an IV antibody candidate
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.
NCT07697560 - Trial Registered
Chengdu Suncadia registers first Phase 1 study of small molecule HRS-8797
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.
NCT07698756 - Trial Registered
Kelun-Biotech adds a fourth NSCLC combination trial for sacituzumab tirumotecan
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.
NCT07697586 - Status Change
Hutchmed advances HMPL-760 PK study to active phase in China
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.
NCT07643272 - Trial Registered
Biomissile registers BM230-PD-1 trial for HER2 tumors, an untested pairing
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.
NCT07698587 - Trial Registered
Haisco opens second HSK41959 trial, pairing PRMT5 drug with chemo
The Chinese oncology sponsor moves its MTAP-deletion PRMT5 inhibitor into combination testing in NSCLC and pancreatic cancer, following a still-recruiting monotherapy study.
NCT07699757 - Trial Registered
Huilun starts Phase 2/3 trial of oral HL-1186 for post-surgical pain in China
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.
NCT07699601 - Status Change
Larkspur opens dosing in first-in-human trial of oral LRK-4189 for advanced tumors
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.
NCT07498725 - Trial Registered
Beijing QL adds cardiac-safety trial for obesity candidate zovaglutide
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.
NCT07697846 - Enrollment Change
LifeMine's LIFE-001 Phase 1 grows to 160 as timeline slips 286 days
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.
NCT06904807 - Trial Registered
InSilico's AI-Designed Rentosertib Enters Phase 3 in IPF, First for TNIK Target
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.
NCT07687459 - Trial Registered
Tiziana registers nasal foralumab ALS trial with no placebo control listed
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.
NCT07688239 - Enrollment Change
Zai Lab expands ZL-1310 trial to 166 patients after 38.2% ORR in NEC data
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.
NCT06885281 - Status Change
QuantX opens dosing in first-in-human QX-4533 trial, target undisclosed
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.
NCT07678463 - Trial Registered
Lingyi Biotech registers third GBA1 gene therapy trial for Parkinson's, joins crowded field
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.
NCT07685444 - Status Change
OnKure stops enrolling PIKture-01 and pushes OKI-219 completion to December 2026
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.
NCT06239467 - Primary Completion Date Change
BMS pushes BMS-986470 sickle cell readout 480 days as enrollment target grows 22%
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.
NCT06481306 - Status Change
Tango's TNG260 trial closes enrollment as third completion-date push lands
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.
NCT05887492 - Trial Registered
AlphaMol Science files first-in-human trial for CSU drug Alpha-0261
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.
NCT07684560 - Status Change
Hansoh Opens Enrollment for HS-20122 Combo in EGFR-Mutant NSCLC
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.
NCT07645222 - Primary Completion Date Change
OnKure pushes OKI-219 first-in-human readout to end of 2026 as enrollment closes
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.
NCT06239467 - Trial Registered
Jacobio Registers 32-Patient Phase 2a for JAB-8263 in Rheumatoid Arthritis
The undisclosed-target compound enters a small, safety-first study with no comparator arm, leaving efficacy, mechanism, and competitive positioning unresolved.
NCT07684157 - Trial Registered
Biostar registers Phase 3 pitting Utidelone capsule against its own injection
The China-only trial tests a formulation switch, not a new mechanism, with no posted primary endpoint threshold and enrollment not yet started.
NCT07684456 - Trial Registered
Minghui advances MH004 to Phase 3 in vitiligo, avoiding the JAK route
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.
NCT07682506 - Trial Registered
Hangzhou Zhongmei Files Generic-Style Roflumilast Trial for China Seborrheic Dermatitis
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.
NCT07683806 - Trial Registered
GenSci144 Enters Crowded PKU Field with a 48-Patient Safety-Only Phase 1
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.
NCT07685210 - Trial Registered
EnnovaBio starts first-in-human trial of topical ENC0653 in China
The Phase 1 safety study enrolls 56 healthy volunteers with no disclosed target or indication, leaving the program's competitive position and mechanism undefined.
NCT07684196 - Trial Registered
Gensciences starts second FRSW107 Phase 3, adding to a crowded Factor VIII field
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.
NCT07684898 - Trial Registered
Roche adds third enicepatide Phase 3, this one testing China-only obesity data
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.
NCT07670416 - Primary Completion Date Change
Imbioray's AML Cell Therapy Trial Slips 2 Years, 5 Months to July 2027
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.
NCT06234904