Recent Results
115The latest resolved clinical catalysts, newest first.
- AMBIGUOUS RESULTS
ENDURANCE trial: two years of lenalidomide matches lifelong maintenance in myeloma
The ECOG-ACRIN Phase 3 trial found near-identical seven-year survival with fixed two-year lenalidomide versus indefinite therapy, while indefinite dosing carried more toxicity and second cancers.
NCT01863550 - TRIAL SUCCESS
Orasis and Aspen file BESKA for presbyopia in Australia on approved Phase 3 data
The NDA leans on NEAR-1 and NEAR-2 results already behind BESKA's U.S. approval, making replication of that Day 8 near-vision gain the bar for Australian regulators, not a new efficacy question.
NCT04599933 - POSITIVE RESULTS
Nutrafol study links its supplement to 19%-37% faster hair growth in women
A peer-reviewed 180-woman study found Nutrafol's Hair Growth Nutraceuticals associated with faster linear hair growth at 6 months, an endpoint rarely measured in hair-thinning research.
NCT06376409 - POSITIVE RESULTS
Ractigen's RAG-17 cuts SOD1 protein 69% in six-patient ALS trial
Published Phase 1 data show the siRNA candidate hit its safety endpoint with no serious adverse events, while CSF SOD1 fell 69% and plasma NfL fell 62% in a first-in-human cohort of six.
NCT05903690 - AMBIGUOUS RESULTS
NeuroThera opens German site for SCI-110 Tourette trial, cites unverified 21% tic drop
The Phase IIb expansion leans on a Phase IIa topline figure that still carries no sample size, p-value, or timepoint, leaving the placebo-controlled trial to supply the first rigorous test.
NCT03651726 - AMBIGUOUS RESULTS
Allogene's ALLO-316 hits 31% response rate in CD70-high kidney cancer
Complete Phase 1 TRAVERSE data show durable responses with an allogeneic CAR T in a population that had exhausted checkpoint inhibitors and TKIs, though the trial remains a 51-patient, uncontrolled study.
NCT04696731 - AMBIGUOUS RESULTS
Kairos reports no severe toxicity in 13 patients on carotuximab-osimertinib combo
The Phase 1 trial's primary endpoint is dose-limiting toxicity, and safety data so far do not report efficacy on the resistance-reversal thesis the company is pitching.
NCT05401110 - AMBIGUOUS RESULTS
Rani's oral RT-114 tops matched injected dose, no drug-related AEs in Phase 1a
A 30-person healthy-volunteer cohort shows Rani Therapeutics' RaniPill-delivered GLP-1/2 agonist clearing subcutaneous exposure, positioning a repeat-dose obesity study for 2026.
NCT06891287 - TRIAL SUCCESS
InnoCare's soficitinib hits both co-primary endpoints in Phase 3 atopic dermatitis trial
The oral TYK2 inhibitor cleared vIGA-AD and EASI-75 goals with no new safety signals, but InnoCare has not yet released the effect sizes that would size the win against approved JAK1 rivals.
NCT06775860 - Journal Publication
Toripalimab surgery data show fewer canceled operations in NEOTORCH
A post hoc analysis of the Neotorch trial ties perioperative toripalimab to lower surgery-cancellation rates and deeper tumor downstaging, both linked to longer event-free survival.
NCT04158440 - AMBIGUOUS RESULTS
Cellectar's iopofosine data show 15.4% response rate in myeloma Phase 1
A published dose-escalation study in heavily pretreated myeloma patients set a maximum tolerated dose and pointed to a fractionated regimen for further testing, six years after the trial finished enrolling.
NCT02278315 - MIXED
Veradermics' oral VDPHL01 posts hair-count gains in small open-label female trial
A 49-patient, uncontrolled Phase 2 readout showed hair-count increases and high patient-reported improvement rates, with the harder registration-directed Study 306 due in 1H 2027.
NCT06527365 - POSITIVE RESULTS
Keytruda monotherapy beats chemo on PFS in dMMR endometrial cancer
KEYNOTE-C93 hit its progression-free survival goal for pembrolizumab alone, but overall survival, the trial's other primary endpoint, remains immature.
NCT05173987 - Journal Publication
GST-HG171 needs lower dosing in kidney disease as impairment raises drug exposure
A China-based renal-impairment study found GST-HG171 exposure rose with worsening kidney function, leading to modeling-based dose cuts for patients with impaired renal clearance.
NCT06106126 - AMBIGUOUS RESULTS
J&J's apalutamide cuts metastasis or death risk in PROTEUS prostate cancer trial
The Phase 3 PROTEUS trial met both co-primary endpoints, with perioperative apalutamide lowering metastasis-free survival risk by 20% ahead of the trial's December 2026 completion date.
NCT03767244 - AMBIGUOUS RESULTS
Nipocalimab hit its SLE endpoint in 2026; J&J's Q2 release restates it without new data
The Phase 2 JASMINE trial met its SRI-4 primary endpoint earlier this year; J&J's July 15 earnings release recaps the finding but adds no new numbers as Phase 3 GARDENIA continues enrolling.
NCT04882878 - Journal Publication
Assay validates lumateperone PK profile in Chinese subjects for the first time
An LC-MS/MS method quantifying lumateperone and its four active metabolites reported the drug's first full pharmacokinetic profile in a Chinese population.
- Journal Publication
Stapokibart post-hoc analysis links eosinophil drop to EASI-75 gains in atopic dermatitis
A pooled analysis of phase II and phase III trials shows stapokibart lowered blood eosinophil counts and paired that drop with higher EASI-75 response, regardless of baseline eosinophil level.
- Journal Publication
Early ivarmacitinib response at week 4 predicted better week-16 outcomes
A post hoc analysis of a phase 3 atopic dermatitis trial found early EASI 75 responders sustained higher skin-clearance and quality-of-life gains through week 52 than late or non-responders.
NCT04875169 - Journal Publication
Preoperative acupoint stimulation cuts post-mastectomy pain in sleep-disturbed patients
A 59-patient trial links preoperative TEAS to lower pain scores and better sleep after breast cancer surgery, with reduced intraoperative blood pressure swings as a possible mechanism.
- Journal Publication
First-in-human data show XT1061 tolerable in healthy volunteers
A Phase Ia study of the hepatitis B capsid assembly modulator XT1061 found dose-proportional exposure and no difference in adverse events versus placebo, clearing the way for patient trials.
- Journal Publication
Escitalopram edges vortioxetine on depression symptom relief at 4 weeks
A 100-patient randomized trial found escitalopram produced lower HAM-D depression scores than vortioxetine at week 4, a difference reaching statistical significance.
- Journal Publication
Post-op dexmedetomidine nasal spray improves sleep, not anxiety, after laparoscopy
A randomized trial found a second nighttime dose of dexmedetomidine nasal spray preserved sleep architecture and shortened hospital stay, but did not separate from control on next-day insomnia scores.
- POSITIVE RESULTS
Kelun-Biotech's sac-TMT plus Keytruda hits PFS goal in PD-L1-negative NSCLC
OptiTROP-Lung06's interim analysis is the first Phase 3 ADC-immunotherapy combination to clear its primary endpoint in driver-negative, PD-L1-negative NSCLC, a segment where checkpoint inhibitors alone underperform.
NCT06711900 - FULL APPROVAL
FDA approves Celcuity's REVTORPYK, first pan-PI3K/mTOR drug, in HR+/HER2- breast cancer
The approval rests on VIKTORIA-1 data showing gedatolisib cut progression risk 76% with palbociclib and 67% without it, versus fulvestrant alone.
NCT05501886 - AMBIGUOUS RESULTS
Annexon frames Phase 2 vonaprument vision data as blueprint for pivotal Phase 3
ARCHER hit vision-preservation measures and photoreceptor protection, but the press release omitted the trial's own registered endpoint, GA lesion growth rate, ahead of Phase 3 ARCHER II data due in Q4 2026.
NCT04656561 - POSITIVE RESULTS
ImmunoBrain's anti-PD-L1 antibody clears safety bar in early Alzheimer's
Phase 1b data published in Nature Medicine show IBC-Ab002 was well tolerated in 40 patients, with CSF biomarker reductions concentrated in the highest-dose group.
NCT05551741 - POSITIVE RESULTS
Cebranopadol clears Phase 3 pain trial, Adneuris licenses China rights
ALLEVIATE-1 hit its pain-reduction endpoint against placebo after abdominoplasty, and Adneuris paired the readout with a Greater China license as it prepares an FDA filing.
NCT06545097 - TRIAL SUCCESS
HUYABIO's HBI-8000 combo nearly doubles PFS versus nivolumab alone in melanoma
The Phase 3 HBI-8000-303 trial hit its primary endpoint at 11.7 versus 7.4 months median PFS, giving the HDAC inhibitor a shot at frontline melanoma where it faces no direct HDAC-class rival.
NCT04674683 - Journal Publication
Trispecific CD19/20/22 CAR T shows 50% response rate in first-in-human trial
Sixteen patients with relapsed or refractory B-cell malignancies received the point-of-care manufactured trispecific CAR T, designed to blunt single-antigen escape that drives relapse after CD19-only CAR T.
- POSITIVE RESULTS
CervoMed's 80mg neflamapimod hits safety goal in small open-label DLB study
The 26-patient Phase 2 trial met its safety and pharmacokinetic objectives, but the company's own Phase 2b trial had already failed to replicate earlier cognitive benefit data in this same drug program.
NCT06815965 - Journal Publication
Ivonescimab plus chemo shows early activity in two recurrent H3K27M glioma cases
A two-patient pilot report finds partial tumor shrinkage and tolerability with an anti-PD-1/VEGF bispecific in a cancer with a typical median survival under a year.
- Journal Publication
Tiragolumab-atezolizumab combo raises rash and infusion-reaction risk, meta-analysis finds
A pooled analysis of five randomized trials in 1,001 patients links dual TIGIT/PD-L1 blockade to more skin and infusion toxicity without a rise in severe adverse events.
- Journal Publication
Warming blankets cut shivering in hypothermic elderly surgery patients
A two-phase Chinese study links traditional-medicine constitution, low BMI, and low pre-op temperature to intraoperative hypothermia, and finds active warming lowered postoperative shivering rates.
- Journal Publication
AI-designed antibody GB-0669 neutralizes SARS-CoV-2 in first human trial
A first-in-human study of an AI-optimized antibody targeting a conserved spike region showed dose-dependent virus neutralization and no dose-limiting toxicity in 51 healthy adults.
- Journal Publication
PD-1-enhanced HIV DNA vaccine ICVAX shows tolerability, T-cell response in Phase 1
A 45-patient placebo-controlled trial found ICVAX safe in ART-treated HIV-1 patients and more likely than placebo to raise antigen-specific T-cell responses, with viral-reservoir effects left for future study.
NCT06253533 - Journal Publication
Neoadjuvant nedaplatin-paclitaxel yields 30.3% pCR in esophageal cancer trial
A single-arm phase II trial found lymph-node status and tumor FOXP3/TIGIT expression tracked survival after chemoradiotherapy in esophageal squamous cell carcinoma.
- Journal Publication
Ciprofol clears slower and sedates deeper in elderly patients, PK/PD study finds
A 40-patient comparative study finds age-related drops in ciprofol clearance drive higher exposure and more adverse events, while sedation depth on key measures stayed equivalent.
- Journal Publication
Third-generation EGFR-TKIs tie each other on PFS in network meta-analysis
A pooled analysis of 11 randomized trials and 4,663 patients finds osimertinib, furmonertinib and six other third-generation EGFR-TKIs all beat first-generation drugs, but not each other, on progression-free survival.
- Journal Publication
Meta-analysis ties PD-(L)1 benefit in gastric cancer to metastasis site, histology
Pooling six phase 3 trials and 5,410 patients, the analysis finds checkpoint inhibitors add little survival benefit when peritoneal metastases or diffuse-type histology are present.
- FULL APPROVAL
FDA approves once-weekly subcutaneous LEQEMBI IQLIK for early Alzheimer's
The approval lets patients start lecanemab with a 15-second weekly injection instead of an IV infusion, backed by exposure data showing the shot matches IV dosing.
NCT03887455 - Journal Publication
Ascentage's pelcitoclax pairs with osimertinib but stalls in resistant NSCLC
A phase 1b trial found the BCL-2/BCL-xL inhibitor drove an 80.8% response rate in TKI-naive patients but only 10.7% after resistance had already set in.
NCT04001777 - Journal Publication
Oral bofanglutide shows sub-2% bioavailability but clean safety in Phase 1
A Chinese healthy-volunteer study found the SNAC-formulated oral GLP-1 well tolerated with only grade 1 GI side effects, though absorption stayed under 1.5% across doses.
- Journal Publication
Oral mesoglycan beats placebo on symptom score in acute hemorrhoidal disease trial
A 52-patient randomized trial found mesoglycan cut the Hemorrhoidal Disease Symptom Score more than placebo over 40 days, with benefits concentrated in grade III disease.
- Journal Publication
60 Gy dose escalation fails to beat 50 Gy in esophageal cancer at 8 years
A phase 3 trial's long-term follow-up confirms escalated radiation adds no survival benefit, while spatial tumor profiling points to why some patients still fail standard-dose chemoradiotherapy.
- POSITIVE RESULTS
Health Canada approves Novartis's Vanrafia for IgA nephropathy proteinuria
The approval rests on the same Week 36 interim UPCR reduction that already won US accelerated approval, with the ALIGN trial's eGFR-based final analysis still to come.
NCT04573478 - Journal Publication
Serum CTRP7 tracks kidney damage severity, tied to dapagliflozin benefit in DKD
A 108-patient cross-sectional study links rising CTRP7 to worsening diabetic kidney disease, and a 48-patient follow-on ties 12 weeks of dapagliflozin to lower albuminuria and reduced oxidative stress markers.
- AMBIGUOUS RESULTS
Spark tAN device raises platelet activity in ear-nerve stimulation study
A 30-person first-in-human study found Spark Biomedical's non-invasive ear stimulation increased platelet function without triggering clotting risk, a hemostasis mechanism with no direct precedent in this class.
NCT05977946 - POSITIVE RESULTS
Sana's hypoimmune islet cells still working without immune drugs at 14 months
A NEJM letter details 14-month follow-up on the first human dosed with UP421, showing the HIP-modified islets survived, evaded rejection and kept producing insulin without immunosuppression.
NCT06239636 - AMBIGUOUS RESULTS
Cochlear's Osia 3 clears FDA on a 29-patient satisfaction result
The SONUS trial backing Cochlear's newest bone conduction processor reported 97% patient satisfaction with sound quality, but disclosed no comparative outcome, safety, or endpoint data against the Osia 2.
NCT07156461 - AMBIGUOUS RESULTS
Posit Science's BrainHQ trial links brain training to acetylcholine marker
The completed INHANCE trial reported a PET imaging signal after speed-of-processing training, with no effect size or p-value disclosed on the record and no controlled comparator drug to benchmark it against.
NCT04149457 - MIXED
Q32 Bio's bempikibart cuts SALT score 35.3% in Part B of severe alopecia trial
The open-label, 33-patient readout hit its primary endpoint with no comparator arm, and Q32 Bio now plans a registration-directed program in H1 2027.
NCT06018428 - TRIAL SUCCESS
ANI Pharmaceuticals' ILUVIEN hits both endpoints in chronic uveitis Phase 4 trial
The SYNCHRONICITY trial showed a 3.6-letter vision gain and a 157.5-micron drop in retinal thickness at six months, backing ILUVIEN's use in retina practices already prescribing it.
NCT05322070 - AMBIGUOUS RESULTS
TolerogenixX Phase Ib safety data cited to back TOL-2 kidney tolerance program
A 14-patient Phase Ib readout completed nine years ago now anchors TolerogenixX's push for EU approval, with the real test, a 63-pair Phase IIb trial, due in H1 2027.
NCT02560220 - Journal Publication
PVA microsphere rhinoplasty holds shape in 30 Asia female patients over 24 months
A single-arm case series links a surgical-like PVA microsphere injection technique to sustained nasal aesthetic gains and low regression, without a comparator arm.
- Journal Publication
Selinexor-tislelizumab shows 75% response after PD-1 blockade failure in NK/T-cell lymphoma
The phase 1b TOUCH trial reports a 75% overall response and 43.8% complete response in 16 checkpoint-exposed patients with relapsed NK/T-cell lymphoma, a population with no established second-line standard.
NCT04425070 - FULL APPROVAL
FDA approves Merck's Keytruda plus Padcev for muscle-invasive bladder cancer
The approval, weeks ahead of its August 17 PDUFA date, rests on a 47% reduction in disease progression or death versus chemotherapy before and after surgery.
NCT04700124 - TRIAL FAIL
Bausch + Lomb's BL1107 eye drop fails glaucoma vision-function goal
The Phase 2 study lowered eye pressure but missed its visual-field endpoint and key vision secondaries, and Bausch + Lomb is dropping the topical program to focus on an implant for geographic atrophy instead.
NCT07168902 - Data Readout
LEO Pharma's tralokinumab clears PK bar in atopic dermatitis children aged 6 to 11
TRAPEDS-1 met its pharmacokinetic objective in 28 children, but the enrollment target was cut nearly in half during the trial and no efficacy data have been released.
NCT05388760 - AMBIGUOUS RESULTS
Elysium's 7-day supplement pilot ties Basis to menopause symptom drops
A 40-woman open-label study with no control arm reported 50%-plus self-reported symptom reductions and a shifted estrogen ratio, results the sponsor now wants a randomized trial to confirm.
NCT04841499 - TRIAL SUCCESS
Astellas builds on IZERVAY's GATHER1 win with new driving and biomarker data
The original GATHER1 result behind IZERVAY's approval is now dated, but Astellas is layering pooled follow-up data on driving eligibility and photoreceptor biomarkers to extend the case at ASRS 2026.
NCT02686658 - POSITIVE RESULTS
Forte's FB102 hits Week 24 vitiligo endpoint in placebo-controlled Phase 1b
FB102 produced a 29.6% mean facial-VASI improvement versus 7.9% for placebo at Week 24, with gains still building after the 12-week dosing period ended.
NCT06905873 - TRIAL SUCCESS
Astellas GATHER2 data confirm IZERVAY slowed GA growth, already an approved drug
Astellas says avacincaptad pegol met its GA-growth primary endpoint in GATHER2, replicating the effect that already won IZERVAY approval, without disclosing new effect sizes.
NCT04435366 - AMBIGUOUS RESULTS
Tris Pharma says cebranopadol beat placebo on pain in Phase 3 ALLEVIATE-1
The launch of a new pain-drug subsidiary carried the topline result, but Tris Pharma disclosed no effect size, p-value, or safety data behind the win.
NCT06545097 - POSITIVE RESULTS
Tris Pharma's cebranopadol beats placebo on pain in second Phase 3 bunionectomy trial
ALLEVIATE-2 hit its primary pain endpoint and cut opioid rescue use, giving the dual NOP/MOP agonist two positive Phase 3 readouts as Tris Pharma's Adneuris unit prepares an NDA.
NCT06423703 - AMBIGUOUS RESULTS
InxMed's ifebemtinib-garsorasib combo posts 82% ORR in first-line KRAS G12C NSCLC
The chemotherapy-free oral pairing hit a response rate and 22.3-month PFS no first-line KRAS G12C regimen has cleared, in a 33-patient single-arm cohort now moving to Phase 3 confirmation.
NCT06166836 - TRIAL FAIL
Ionis and AstraZeneca's eplontersen misses primary endpoint in ATTR-CM trial
CARDIO-TTRansform did not beat placebo on CV death and recurrent events in 1,432 patients, though a monotherapy subgroup and TTR reduction data complicate the read.
NCT04136171 - TRIAL SUCCESS
Ipsen's Dysport hits primary endpoint in chronic migraine Phase 3
C-BEOND met its week-24 monthly-migraine-day endpoint versus placebo, positioning Dysport as a candidate first-in-class botulinum toxin across both migraine types.
NCT06047444 - TRIAL SUCCESS
Ipsen's Dysport hits primary endpoint in Phase 3 episodic migraine trial
E-BEOND is the first Phase III trial of a botulinum toxin to show a statistically significant cut in monthly migraine days versus placebo in episodic migraine.
NCT06047457 - POSITIVE RESULTS
Betta's ensartinib cuts ALK-positive NSCLC recurrence risk 80% in Phase 3
The ELEVATE trial's adjuvant ensartinib arm hit 86.4% 2-year disease-free survival versus 53.5% on placebo, and Betta says China has already accepted its marketing application.
NCT05341583 - AMBIGUOUS RESULTS
Tarsus-acquired IRX-101 cuts injection pain and corneal damage versus iodine antiseptic
The completed 154-patient RELIEF trial hit statistical significance on pain and corneal staining, but the trial's own registered safety endpoint result was not disclosed in the acquisition announcement.
NCT05747430 - AMBIGUOUS RESULTS
Beurer's heat device cut mosquito-bite itch nearly in half in small trial
A 22-person German registry trial and a 1,750-person published study both tie concentrated heat applied to the bite site to faster itch relief than no treatment, with no drug involved.
DRKS00033004 - AMBIGUOUS RESULTS
Octapharma's wilate wins FDA nod for VWD prophylaxis in kids under 6
The expanded approval rests on a 12-patient Phase 3 trial showing an annualized bleeding rate of 4.6, with no thrombotic events, in the first VWF concentrate cleared for prophylaxis across all VWD ages.
NCT04953884 - AMBIGUOUS RESULTS
Cardiac Dimensions touts 10-year survival data from single-center mitral device study
A single-center extension of the completed REDUCE FMR trial reports 66% ten-year survival with no control comparison, as the sponsor's real evidence for U.S. approval now rests on the ongoing sham-controlled EMPOWER trial.
NCT02325830 - AMBIGUOUS RESULTS
Miach's BEAR implant registry shows 5% ACL retear rate at two years
Modified surgical technique tracked with the same 5% retear rate seen in a published 100-patient cohort and cut reoperations, but the Bridge Registry has no comparator arm.
NCT05398341 - AMBIGUOUS RESULTS
Eledon's tegoprubart: all evaluable islet-transplant patients reach insulin independence
An investigator-initiated Chicago trial reports every evaluable patient off insulin more than four weeks post-transplant, with no graft rejection, though the readout comes from a press release, not a peer-reviewed dataset.
NCT06305286 - TRIAL SUCCESS
Lilly secures Canada-wide reimbursement pathway for Ebglyss in eczema
A pCPA letter of intent follows CDA-AMC's conditional recommendation, opening public drug-plan access nationally for a Phase 3-proven IL-13 blocker already approved by Health Canada.
NCT04146363 - POSITIVE RESULTS
Chemomab's nebokitug hits safety bar in PSC as sponsor merges to pivot into RA
The Phase 2 SPRING trial met its primary safety endpoint and showed biomarker improvement in primary sclerosing cholangitis, but Chemomab is folding into Scipher Medicine to chase a 2028 rheumatoid arthritis readout instead.
NCT04595825 - TRIAL SUCCESS
Keenova's XIAFLEX hits pain endpoint in first pivotal trial for Ledderhose disease
The Phase 3 STRIDE trial met its primary pain endpoint and key secondary measures, positioning Keenova to file the first drug application for plantar fibromatosis in the fourth quarter of 2026.
NCT06151197 - TRIAL SUCCESS
Seres' SER-155 hits 80% response rate in checkpoint-inhibitor colitis pilot
A 15-patient investigator-run trial at Memorial Sloan Kettering found most patients cleared diarrhea without steroids, but the benefit faded by Day 43 for more than half.
NCT06801067 - AMBIGUOUS RESULTS
Satellos shows fat-fraction drop, strength stability in 4 DMD adults on SAT-3247
Six-month TRAILHEAD data in four adults link SAT-3247 to reduced muscle fat and stable strength, but the interim readout carries no p-values and no comparator in a disease with no cure.
NCT06867107 - ACCELERATED APPROVAL
FDA grants accelerated approval to Vera's TRUTAKNA for IgA nephropathy
The approval rests on a 42% proteinuria reduction versus placebo from an interim ORIGIN 3 analysis, making TRUTAKNA the first dual BAFF and APRIL inhibitor cleared for the disease.
NCT04716231 - POSITIVE RESULTS
Insilico's TNIK inhibitor posts +98.4 mL FVC edge, advances to Phase III in IPF
GENESIS-IPF's Phase IIa readout on rentosertib cleared its safety bar and showed a FVC signal versus placebo, and Insilico has now moved the once-daily oral drug into a 320-patient Phase III trial.
NCT05938920 - AMBIGUOUS RESULTS
Oragenics reports no serious adverse events yet in ONP-002 concussion trial
The July update activates all three Australian sites and clears a safety bar, but leaves the symptom-reduction result that defines the Phase 2a trial for a Q4 2026 readout.
NCT06870240 - AMBIGUOUS RESULTS
Veru's enobosarm preserves lean mass with GLP-1 in Phase 2b, but posts no numbers
The QUALITY trial reported lean-mass and fat-loss benefits with enobosarm plus semaglutide in older adults, yet Veru disclosed no effect size, p-value, or safety data.
NCT06282458 - TRIAL SUCCESS
Hengrui's oral GLP-1 pill HRS-7535 hits 10.9% weight loss in China Phase 3
HARBOR-1 met its primary endpoint against placebo, positioning the oral small molecule among the first Phase 3 obesity readouts for this drug class in China.
NCT06904105 - TRIAL SUCCESS
Hengrui's oral HRS-7535 matches dapagliflozin on HbA1c in Phase 3 diabetes trial
OUTSTAND-2 hit its non-inferiority bar against dapagliflozin, and the 90 mg dose topped it on HbA1c, positioning an oral GLP-1 pill against China's SGLT2 standard of care.
NCT06589765 - AMBIGUOUS RESULTS
Compass's COMP360 holds depression benefit to 26 weeks after two doses
39% of patients on the 25 mg dose sustained a meaningful MADRS improvement from Week 6 through Week 26 in COMP006, as Compass moves toward a Q4 2026 NDA filing.
NCT05711940 - AMBIGUOUS RESULTS
TIXiMED's TIX100 clears Phase 1a safety bar, moves to 28-day dosing study
The oral TXNIP inhibitor was well tolerated across four single-dose cohorts and lowered post-meal glucose swings in healthy volunteers, clearing the way for a placebo-controlled multiple-dose study.
NCT06800729 - AMBIGUOUS RESULTS
Xeltis launches aXess in Europe on 12-month patency data matching mature AVFs
The European pivotal readout reported patency comparable to matured fistulas and fewer reinterventions than historical grafts, but posted no numeric results or comparator arm alongside the launch.
NCT05473299 - AMBIGUOUS RESULTS
Cyllene reports sustained incontinence drop with EG110A gene therapy in 16-patient trial
The Phase 1/2 readout in spinal-cord-injury patients reports durable incontinence reductions at 9 months, but Cyllene disclosed no incidence numbers, p-values, or comparator data.
NCT06596291 - Journal Publication
IBR854 shows no dose-limiting toxicity in 19-patient NK cell trial for tumors
The first-in-human, open-label study of a 5T4-targeted allogeneic NK cell therapy reported a 43.8% disease control rate but only 43 days of median progression-free survival, leaving durability unresolved.
NCT06001684 - POSITIVE RESULTS
Orelabrutinib cuts CLL progression risk 68% versus chlorambucil-rituximab
The Phase 3 ICP-022 trial hit its primary endpoint with a hazard ratio of 0.32, but the trial's own registry status reads Unknown, exposing a gap between published data and registry housekeeping.
NCT04578613 - Journal Publication
Personalized DC vaccine hits safety bar in 11-patient glioblastoma trial
The phase 1b abstract shows median PFS of 16.2 months and no OS reached, but the safety-only design and n=11 leave efficacy unproven.
NCT04968366 - Journal Publication
Staidson's C5a antibody STSA-1002 clears Phase 1 safety bar in China
Multiple IV doses up to 20 mg/kg suppressed free C5a through Day 56 in 26 healthy volunteers, but the model's 4.1% endpoint-met read reflects a PK/PD bar, not a China-to-Phase-2 efficacy signal.
NCT05497635 - Journal Publication
ETER100 renal safety analysis clears combo of no added kidney toxicity
A secondary analysis of the Phase 3 ETER100 trial shows benmelstobart plus anlotinib matched sunitinib on renal injury measures, but the trial's PFS primary endpoint result remains undisclosed.
NCT04523272 - Journal Publication
GCAR1 CAR T cell holds one ASPS patient's disease stable for 3 months
A single-participant, post hoc interim look at a first-in-human trial shows GPNMB-targeted CAR T is tolerable and biologically active, not yet proof of efficacy.
NCT07104682 - Journal Publication
Bimekizumab 3-year data show durable work-productivity gains in PsA, axSpA
The July 1 abstract reports Year 3 quality-of-life and work-impairment data, not a new pivotal endpoint, from patients who stayed on bimekizumab through open-label extensions of two approved Phase 3 programs.
NCT03896581 - Journal Publication
HengRui's SHR-A1811 cuts progression risk 78% versus pyrotinib in HER2+ breast cancer
Interim HORIZON-Breast01 data show median PFS of 30.6 months versus 8.3 months, but the trial remains open and final results are not yet in.
NCT05424835 - Journal Publication
Sonrotoclax hits 52.4% ORR in MCL, already backing an FDA accelerated approval
The Phase I/II abstract confirms the data behind BEQALZI's May 2026 approval, but PFS of 6.5 months trails the durability bar BeOne will need to defend at confirmatory review.
NCT05471843 - FULL APPROVAL
FDA approves Orca Bio's Tregzi after Precision-T cut chronic GVHD-free survival gap
The Phase 3 Precision-T trial showed 78% of Tregzi recipients free of chronic GVHD or death at 12 months versus 38% on standard transplant, and the FDA approved the cell therapy days ahead of its July 6 target date.
NCT05316701 - TRIAL FAIL
Vistagen's fasedienol misses PALISADE-4 goal; subgroup signal seen
The Phase 3 trial of intranasal fasedienol missed its primary anxiety-relief endpoint in social anxiety disorder, and Vistagen is now pointing to a post-hoc subgroup and a redesigned pathway.
NCT06615557 - FULL APPROVAL
FDA approves Arcutis's Zoryve cream for plaque psoriasis in children as young as 2
The approval, based on a 4-week pharmacokinetics and safety study, extends Zoryve's label below the age of 6 and marks the drug's seventh FDA nod in four years.
NCT04746911 - FULL APPROVAL
FDA grants full PMA approval to Artivion's AMDS aortic dissection device
The approval eliminates the humanitarian-exemption IRB requirement and rests on PERSEVERE data showing a 72% relative cut in 30-day mortality versus hemiarch repair alone.
NCT05174767 - TRIAL SUCCESS
Otsuka's centanafadine beats placebo on ADHD and anxiety in Phase 3b trial
The 315-patient study hit its primary endpoint in adults with ADHD and comorbid anxiety, adding a second symptom domain to the drug's evidence base weeks before its FDA decision.
NCT06973577 - COMPLETE RESPONSE LETTER
Achieve gets CRL for cytisinicline over manufacturing, not efficacy or safety
The FDA cited third-party manufacturing and labeling issues, not the drug's clinical data, and Achieve plans to resubmit in Q4 2026 with a new manufacturing partner.
NCT04576949 - TRIAL SUCCESS
Definium's single-dose DT120 clears MDD Phase 3 with an 8.1-point MADRS edge
Emerge, the first of two pivotal Phase 3 studies for the 5-HT2A psychedelic, hit its primary endpoint with rapid, durable separation from placebo and no new safety signal.
NCT06941844 - FULL APPROVAL
FDA approves Bayer's Ambelvist, a lower-dose gadolinium MRI contrast agent
The approval rests on Phase 3 QUANTI data showing lesion visualization at 0.01 mmol/kg comparable to existing agents dosed at twice to five times the gadolinium load.
NCT05915728 - FULL APPROVAL
FDA approves Keytruda plus Welireg as first adjuvant regimen in kidney cancer
The combination cut recurrence or death risk by 28% versus Keytruda alone, the first HIF-2α and PD-1 combination to reach approval in earlier-stage clear cell renal cell carcinoma.
NCT05239728 - NEGATIVE RESULTS
Praxis' vormatrigine misses main goal in POWER1 focal seizure trial
The Phase 2/3 study missed its primary seizure-frequency endpoint, but a secondary responder measure hit and the higher 30 mg dose showed more seizure reduction late in the trial.
NCT06999902 - TRIAL FAIL
Oculis's OCS-01 eye drop misses primary endpoint in DME despite thickness benefit
Both Phase 3 DIAMOND trials failed on visual acuity at week 52, and Oculis said it will not pursue an FDA filing for OCS-01 in diabetic macular edema.
NCT06172257 - FULL APPROVAL
MannKind wins FDA approval for Afrezza in children as young as 6
The approval, backed by the Phase 3 INHALE-1 trial, makes Afrezza the first inhaled mealtime insulin option for pediatric patients after a century of injection-based therapy.
NCT04974528 - COMPLETE RESPONSE LETTER
FDA clears Unicycive's OLC for hyperphosphatemia after 2025 CRL
The FDA accepted Unicycive's resubmitted NDA and set a June 29, 2026 PDUFA date a year after a manufacturing-related complete response letter forced the restart.
NCT06218290 - Journal Publication
Incretin obesity drugs spare muscle function despite mild lean-mass loss, study finds
A mouse-and-human analysis finds weight loss from incretin-based therapies comes mostly from fat and liver mass, with muscle-to-bodyweight ratio and strength relative to weight improving rather than declining.
- Journal Publication
Botanical CL19183 cuts body weight and fat versus placebo in 16-week RCT
A randomized, placebo-controlled trial of the citrus-cacao extract combination Theolim showed greater weight loss, fat loss, and resting metabolic rate gains in overweight adults.