The front page of AI-driven biology
Thursday, October 15, 2026Thu, Oct 15
Updated 6:32 PM PT
The biotech's brain-penetrant oral EGFR inhibitor firmonertinib failed to significantly improve progression-free survival against platinum-based chemotherapy as a first-line treatment for non-small cell lung cancer with exon 20 insertion mutations.
The biotech adjusted its Phase 2 protocol to evaluate its CD105 inhibitor ENV-105 combined with Astellas and Pfizer's Xtandi against monotherapy immediately after patients show rising PSA levels.
ViiV Healthcare said its long-acting injectable combination of cabotegravir, an integrase strand transfer inhibitor, and rilpivirine, a non-nucleoside reverse transcriptase inhibitor, achieved superior viral suppression rates at six months compared to standard daily oral therapy.
Adding Epkinly, a bispecific antibody targeting CD3 and CD20, to standard R-CHOP chemotherapy reduced the risk of disease progression or death by 51% in patients with newly diagnosed diffuse large B-cell lymphoma.
In the Opus-1 Phase 3 trial in adults, the company's 31-valent pneumococcal conjugate vaccine, VAX-31, met non-inferiority criteria against all 20 bacterial strains in Pfizer's Prevnar 20 and 17 of 19 strains in Merck's Capvaxive.
Updated clinical data for EPI-321 showed a 3% increase in muscle volume at six months in patients with facioscapulohumeral muscular dystrophy, or FSHD.
In Part C of the Phase 1/2 Rainfol-01 trial of 109 patients with platinum-resistant ovarian cancer, Genmab reported a median progression-free survival of 9.5 months for its folate-receptor-alpha-targeting antibody-drug conjugate rinatabart sesutecan.
Aviceda Therapeutics is closing down after its lead eye-disease asset, the glyco-engineered nanoparticle AVD-104, failed a Phase 2b trial against Astellas' Izervay in geographic atrophy.
Pfizer reported that its trispecific antibody tilrekimig met its primary endpoint in a Phase 2 trial, producing significant skin clearance over placebo in patients with moderate to severe atopic dermatitis.
Eli Lilly has ended its 2021 oncology alliance with Foghorn Therapeutics after dose-escalation Phase 1 data for FHD-909 showed insufficient tumor-shrinking efficacy in non-small cell lung cancer with SMARCA4 mutations.
Bristol Myers Squibb reported that a participant in its Phase 3 Aloft program died of multi-organ failure tied to acute liver injury, though the trial remains blinded and it is unknown if the patient received the experimental pill admilparant or a placebo.
Invivyd reported that its injectable monoclonal antibody VYD2311 achieved significantly better tolerability than Pfizer's mRNA vaccine Comirnaty in the Phase 3 LIBERTY study.
Boehringer Ingelheim and Zealand Pharma reported that their dual glucagon and GLP-1 receptor agonist met co-primary endpoints in the Phase 3 Synchronize-2 trial in adults with obesity and Type 2 diabetes.
Eli Lilly reported that its dual-drug combination eloraTZP delivered 23.3% average weight loss at 48 weeks in a trial of 367 adults with both type 2 diabetes and obesity or overweight.
Merck announced that its antibody tulisokibart met the primary and secondary endpoints in a 149-patient Phase 2b trial for moderate to severe hidradenitis suppurativa, an inflammatory skin condition.
Primary endpoint Phase 2 data published in The Lancet Diabetes & Endocrinology showed Zealand Pharma and Roche's amylin analog, petrelintide, produced 9.8% mean weight loss at Week 28 on a 5 mg dose compared to 1.7% on placebo.
Pierre Fabre Laboratories has resubmitted its biologics license application for Ebvallo, an allogeneic T-cell therapy targeting a complication of Epstein-Barr virus infections that the FDA rejected twice over manufacturing problems.
In a 159-patient Phase 2 trial, the company's experimental antibody rademikibart cut new moderate-to-severe lung attacks by 85% and reduced overall treatment failure by 81% over 28 days compared to placebo.
In a 72-patient Phase 2 trial in discoid lupus, the low dose of the monoclonal antibody daxdilimab delivered a 6-point reduction against placebo on the skin-severity index at Week 24, while a higher dose achieved a 5.7-point reduction.
Eli Lilly presented full results from the 1,152-patient Triumph-2 Phase 3 trial testing retatrutide, an injectable triple agonist targeting GIP, GLP-1, and glucagon receptors, in adults with obesity and Type 2 diabetes.
Highlight Therapeutics reported that its intralesional double-stranded RNA nanoparticle, BO-112, achieved a 61% combined visual and pathological response rate at week 24 in a 46-patient Phase 2b trial for localized basal cell carcinoma.
Updated 48-month data from 12 patients in a Phase 1/2 trial of the gene therapy AMT-130 showed a 44% slowing of disease progression on the composite Unified Huntington's Disease Rating Scale, down from 75% at three years and missing statistical significance against an external control.
Adicet Bio reported early clinical data for prula-cel, an allogeneic, donor-derived gamma delta CAR-T cell therapy, demonstrating efficacy competitive with autologous benchmarks in patients with lupus.
Mirum Pharmaceuticals reported that subcutaneous brelovitug, an antibody targeting hepatitis surface antigen, achieved composite response rates of 56% for weekly 300 mg doses and 45% for monthly 900 mg doses, against 0% in a 24-week delayed-treatment control arm.
Roche has discontinued development of emugrobart and returned the antibody to its Japanese subsidiary Chugai after a Phase 2 trial interim analysis showed it was unlikely to meet its endpoints.
Merck has stopped supplying Recarbrio, an intravenous antibiotic combination used for severe hospital-acquired pneumonia, complicated urinary tract infections, and resistant intra-abdominal infections in patients with few other options.
In the Phase 3 Daybreak study in wet age-related macular degeneration, Kodiak Sciences showed that tarcocimab tedromer matched Regeneron's VEGF inhibitor aflibercept on the primary vision-gain endpoint at one year.
Acadia Pharmaceuticals said its Phase 2 Radiant trial evaluating remlifanserin in patients with Alzheimer's psychosis missed its primary endpoint with a p-value of 0.0603.
Merck announced that its experimental therapy met the primary endpoint in a mid- to late-stage trial evaluating adult patients with vascular eye disease affecting the retina.
Kyverna Therapeutics reported that a single dose of its autologous cell therapy mivocabtagene autoleucel (miv-cel) maintained a 49% median improvement in mobility at 12 months in a 26-patient registrational trial for stiff person syndrome.