Latest Biotech News

Merck closed a large licensing agreement with China’s Scibrunch Therapeutics for an oncology candidate targeting KRAS G12D, paying $400 million upfront with development and commercialization...

Kodiak Sciences reported Phase 3 success for two wet age-related macular degeneration programs, targeting Eylea (aflibercept) with individualized dosing strategies. The company said tarcocimab...

Mirum Pharmaceuticals reported Phase 3 “victory” in chronic hepatitis delta, building momentum after its acquisition of the program. The company said more than half of patients treated with a...

Researchers at Washington University School of Medicine in St. Louis reported preclinical data showing that blocking CXCR3 can reduce T-cell infiltration and limit neurodegeneration in a mouse...

Adicet Bio reported early clinical evidence that its off-the-shelf CAR-T approach, prula-cel, can induce complete kidney responses and remission in lupus nephritis patients. After one year of...

Daiichi Sankyo and Merck withdrew their BLA for ifinatamab deruxtecan in extensive-stage small-cell lung cancer after FDA feedback, according to the report. The companies said they voluntarily...

Nutshell Therapeutics received FDA IND clearance for NTS-231, a covalent allosteric molecular glue degrader designed to induce NRF2 degradation by covalently binding KEAP1. The company said the...

Vasomune Therapeutics completed enrollment in its Phase 2a trial of pegevongitide (AV-001) for patients hospitalized with pneumonia requiring supplemental oxygen. The randomized, double-blind,...

Scynexis secured a new Biomedical Advanced Research and Development Authority (BARDA) contract worth $214 million to develop SCY-247 for invasive fungal infections. The agreement expands the...

Veeva unveiled an AI agent designed to speed clinical trial study configuration for its EDC and Data Quality System customers. Veeva said Study Builder ingests a study protocol and, using agentic...

Kodiak Sciences said its two late-stage eye therapies for wet age-related macular degeneration achieved statistical equivalence to Regeneron’s Eylea in a Phase 3 trial. The company reported that...

Adicet Bio reported early efficacy and safety data for its donor-derived, allogeneic CAR-T approach in lupus nephritis, with half of evaluable patients achieving a complete kidney response at one...

Nutshell Therapeutics (Shanghai) said the FDA cleared its IND for NTS-231, a covalent allosteric molecular glue degrader targeting NRF2. The company said it identified NTS-231 using its Allostar...

Scynexis secured a new BARDA contract worth $214 million to develop a treatment for invasive fungal infections. The award expands federal support for SCY-247, which Scynexis is developing with...

Vasomune Therapeutics completed enrollment in a randomized Phase 2a trial evaluating pegevongitide (AV-001) in patients hospitalized with pneumonia requiring supplemental oxygen. The company is...

Roche said it ended development of an obesity candidate after an interim analysis in a Phase 2 trial suggested the program had limited likelihood of meeting its endpoints. The company halted work...

Merck said it is paying $400 million upfront to license a KRAS G12D inhibitor from China’s SciBrunch Therapeutics, according to the report. The deal values the license at $2.13 billion if future...

Merck and Daiichi Sankyo said they withdrew an FDA accelerated approval application for their B7-H3 ADC, I-DXd, in a specific small cell lung cancer population after FDA feedback indicated the...

Mirum Pharmaceuticals reported that a Phase 3 trial of its chronic hepatitis delta virus therapy candidate hit its primary endpoint. The result advances Mirum’s effort to compete in a space that...

Mirum Pharmaceuticals said the FDA approved Atebrioz, an oral therapy for fibrodysplasia ossificans progressiva, an ultra-rare disorder characterized by progressive bone formation in soft tissue....