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ARPA‑H funds non‑animal safety models: $31.7M PREDICTS award
ARPA‑H awarded up to $31.7 million to a PREDICTS consortium led by Ginkgo Bioworks and Deep Origin to develop non‑animal in silico and ex vivo systems for drug safety and dosing prediction. The...
Mirum snaps up Bluejay — $620M for hepatitis D antibody
Mirum Pharmaceuticals agreed to acquire Bluejay Therapeutics to gain brelovitug, a late‑stage monoclonal antibody for chronic hepatitis D virus (HDV). The deal pays roughly $620 million in cash...
Pfizer doubles down on oral GLP‑1: $150M upfront deal
Pfizer committed $150 million upfront in a deal to secure an oral small‑molecule GLP‑1 candidate from a Fosun subsidiary as part of a renewed push into obesity therapies. The move follows Pfizer’s...
Structure fights back — oral GLP‑1 posts strong Phase IIb data
Structure Therapeutics reported robust Phase IIb results for its oral GLP‑1 candidate aleniglipron showing up to ~15% weight loss, re‑establishing the company in the small‑molecule obesity race....
FDA tells CAR‑T developers: prove superiority over existing therapies
The FDA’s biologics chief signaled a policy shift requiring many oncology CAR‑T programs to demonstrate superiority against existing therapies rather than rely on single‑arm or non‑comparative...
Dyne wins pivotal Duchenne study — prepping FDA filing
Dyne Therapeutics reported that its Duchenne muscular dystrophy (DMD) exon‑skipping candidate met the primary endpoint in a registrational study and plans to advance an FDA filing in 2Q next year....
BioNTech CTLA‑4 drug halves mortality in lung cancer — tolerability caveat
BioNTech and OncoC4 reported Phase III survival data for their anti‑CTLA‑4 antibody in lung cancer showing a greater than 50% reduction in risk of death in the trial population. The survival...
Kymera’s twin wins: degrader biomarker activity and Dupixent‑competitive pill
Kymera Therapeutics reported two notable clinical developments: an oral STAT6 degrader produced biologics‑like biomarker activity in a Phase Ib atopic dermatitis study, and its oral pill KT‑621...
Ianalumab delivers durable platelet control in ITP — Phase III evidence
Phase III VAYHIT2 data showed that ianalumab, a BAFF‑receptor‑targeting monoclonal antibody, delivered prolonged disease control in immune thrombocytopenia (ITP), with over half of patients...
GSK walks away from Ideaya collaboration — hands back two programs
GSK terminated its 2020 licensing agreement with Ideaya Biosciences and returned two clinical programs to the California biotech. The split follows prior reductions in the collaboration and leaves...
Novartis inks $1.7B pact with AI biotech Relation for immuno‑derm targets
Novartis struck a multi‑program discovery collaboration with Relation, a London‑based AI‑enabled biotech, for immuno‑dermatology target identification worth up to $1.7 billion in milestones plus...
Dyne’s Duchenne win: pivotal study hits endpoint, FDA filing planned
Dyne Therapeutics announced that its Duchenne muscular dystrophy (DMD) candidate met the primary endpoint in a pivotal study and the company is preparing an accelerated approval filing with the...
Mirum buys Bluejay for $620M — gains Phase 3 HDV antibody
Mirum Pharmaceuticals agreed to acquire Bluejay Therapeutics for $620 million in cash and stock to obtain brelovitug, a Phase 3-stage monoclonal antibody targeting hepatitis D virus (HDV) and...
Kymera degrader readout: biologics-like biomarker activity sparks rally
Kymera Therapeutics reported Phase Ib biomarker activity from its oral STAT6 degrader program in atopic dermatitis that the company and analysts described as 'biologics-like' and sent the stock up...
Structure back in oral GLP‑1 race — mid-stage data show double-digit weight loss
Structure Therapeutics reported strong Phase IIb data for its oral GLP-1 candidate aleniglipron, showing up to 15% mean weight loss in a mid-stage study and sending investor interest higher....
KRAS G12D race: more than 20 programs launched as companies target common mutation
BioCentury reported a surge of KRAS G12D-targeting programs, with more than 20 initiatives launched in the past year as companies move to drug the most common KRAS mutation in solid tumors. The...
BioNTech CTLA‑4: Phase 3 survival benefit — tolerability challenge emerges
BioNTech and OncoC4 reported Phase 3 data showing their anti‑CTLA‑4 antibody improved overall survival in lung cancer, with the initial headline-grabbing efficacy tempered by a tougher...
Anito‑cel strengthens best‑in‑class hopes — Gilead preps launch
Gilead and Arcellx presented pivotal-stage data for anito‑cel showing deep, durable responses in multiple myeloma, positioning the CAR‑T product as a potential best‑in‑class therapy ahead of a...
FDA raises bar for CAR‑T: new guidance demands superiority evidence
Vinay Prasad, director in FDA biologics, and agency commentary signaled a higher evidentiary bar for new CAR‑T approvals, arguing that novel cell therapies must demonstrate superiority over...
ASH: MRD surrogate in AML — pooled data advocates faster approvals
Researchers presented pooled Harmony Alliance data at ASH supporting measurable residual disease (MRD) as a surrogate endpoint in acute myeloid leukemia (AML), arguing it could identify effective...