The front page of AI-driven biology
Thursday, October 15, 2026Thu, Oct 15
Updated 5:32 PM PT
Following positive Phase 3 adjuvant melanoma results reported in August, the partners are preparing regulatory submissions for intismeran autogene given alongside Keytruda, an anti-PD-1 antibody.
France-based Osivax reported that its influenza A candidate OVX836 achieved a vaccine efficacy of 24% in a Phase 2b trial of 2,850 healthy European adults, missing the 50% bar required by the primary endpoint.
In an early Phase 1/2 trial, Verastem Oncology reported an overall response rate of 41% among 22 patients with advanced pancreatic ductal adenocarcinoma treated with its daily pill VS-7375.
Verdiva Bio has terminated a Phase 2 trial testing its once-weekly oral GLP-1 peptide, VRB-101, as a maintenance treatment for patients switching off injectable weight-loss drugs.
Biomea Fusion reported early trial results for BMF-650, its oral small-molecule GLP-1 receptor agonist, showing mean weight reductions between 1.5% and 3.2% across four cohorts at Day 29.
ARO-MAPT, an experimental RNA interference medicine delivered by simple injection under the skin, lowered tau protein levels by up to 85% in healthy volunteers.
The Merck KGaA spinout demonstrated a 20.8-month median overall survival in a 44-patient Phase 1 trial evaluating roginolisib, an oral small-molecule PI3K delta inhibitor, across advanced malignancies including second-line metastatic uveal melanoma.
Syndax Pharmaceuticals and Incyte have halted development of their CSF-1R-blocking antibody Niktimvo (axatilimab) for idiopathic pulmonary fibrosis after a Phase 2 trial failed to meet its primary endpoint.
The therapeutic mRNA cancer vaccine BNT113 failed to show a statistically significant improvement in progression-free survival when added to Merck's Keytruda in HPV16-positive head and neck cancer.
Nurix Therapeutics announced in its third-quarter earnings report that it is discontinuing clinical development of zelebrudomide, an oral BTK and cereblon neosubstrate degrader.
Caribou Biosciences announced it is halting clinical development of its two allogeneic CAR-T cell therapies, conducting a substantial workforce reduction, and evaluating strategic alternatives.
The FDA cleared Hovilpri (pritelivir), an oral viral helicase-primase inhibitor, to treat refractory mucocutaneous herpes simplex virus infections in immunocompromised adults failing standard nucleoside therapies.
Mirum Pharmaceuticals reported that Livmarli met its primary endpoint in a Phase 3 study, significantly reducing severe pruritus in patients with rare liver disease.
Detailed Phase 3 data for Merck's diabetic macular edema candidate remigromig showed adverse events related to proliferative diabetic retinopathy in 6.7% and 6.1% of patients depending on the dose, compared to 0.9% for Lucentis.
Partner Hansoh Pharma reported that obuprazine significantly cut schizophrenia symptoms compared to placebo across five doses in a Phase 2b trial of 363 adults in China.
The FDA will review Roche's intravitreal IL-6 inhibitor vamikibart for uveitic macular edema, setting an action date of July 2027.
Bristol Myers Squibb announced that both its oral LPA1 blocker admilparant in idiopathic pulmonary fibrosis and its targeted radiotherapy RYZ101 in neuroendocrine tumors met their primary endpoints in late-stage trials.
AstraZeneca attributed the failure of its Phase 3 HICKORY trial for efzimfotase alfa to an imbalanced adult subgroup.
City Therapeutics set terms to raise up to $184.7 million in a Nasdaq initial public offering, yielding expected net proceeds of $158.3 million at the midpoint of its $17 to $19 price range, matching the $158 million target reported by Endpoints News.
In the Phase 3 EXCALIBER-RRMM trial, patients receiving the oral cereblon E3 ligase modulator Zenbexus (iberdomide) combined with standard therapies reached a median progression-free survival of 42 months, compared to 20 months for standard DVd therapy.
Endeavor BioMedicines announced that its oral Hedgehog inhibitor, taladegib, met the primary endpoint in a Phase 2b trial of 213 patients with idiopathic pulmonary fibrosis.
The US Food and Drug Administration placed a clinical hold on American sites testing evenamide, Newron Pharmaceuticals' oral voltage-gated sodium channel blocker for schizophrenia, after four patient deaths occurred during the late-stage study.
Topline Phase 2 data from 220 patients with obesity and Type 2 diabetes showed petrelintide drove up to 9.2% weight loss at 28 weeks compared to 2% for placebo, matching competitive amylin-agonist benchmarks.
Argenx said its anti-CD122 monoclonal antibody, FB102, significantly improved gut tissue architecture compared to placebo in a 126-patient Phase 2 trial of adults undergoing an oral gluten challenge.
China's drug agency approved a Phase 1/3 trial and the FDA cleared a Phase 1/2 trial for NouvSight001, an off-the-shelf cell therapy for the inherited blinding condition retinitis pigmentosa.
The oral GPR6 inverse agonist, evaluated as an add-on to levodopa in 341 patients experiencing motor fluctuations, met its primary goal by cutting daily OFF time by 0.61 hours versus placebo at 12 weeks.
In the Phase 1/2 portion of the Lighthouse trial, six of nine patients with X-linked retinoschisis who received the Phase 3 dose of ATSN-201 met the microperimetry response criteria, compared with zero of three untreated controls.
Caribou Biosciences will close and discontinue its clinical pipeline after failing to secure capital for a Phase 3 study of its lead allogeneic CAR-T therapy, vispa-cel.
MimiVax reported that its cancer vaccine, SurVaxM, narrowly missed its primary overall survival endpoint in a Phase 2b trial for glioblastoma.
Nuvig Therapeutics has halted a Phase 2 trial of its lead fusion protein, NVG-2089, in chronic inflammatory demyelinating polyradiculoneuropathy, a rare nerve disorder.