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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...
Terns rises as Novartis rival: leukemia drug posts strong molecular responses
Terns Pharmaceuticals reported early clinical data showing its oral targeted agent TERN‑701 produced high major molecular response rates in heavily pretreated chronic myeloid leukemia (CML)...
Mirum snaps up Bluejay: $620M buy brings phase‑3 hepatitis D antibody
Mirum Pharmaceuticals agreed to acquire Bluejay Therapeutics for roughly $620 million in cash and stock to secure brelovitug, a monoclonal antibody in late‑stage testing for chronic hepatitis D...
Dyne readies FDA push: Duchenne exon‑51 drug posts landmark dystrophin gains
Dyne Therapeutics reported pivotal study success for its exon‑51 skipping therapy in Duchenne muscular dystrophy (DMD) and said it will move toward an accelerated approval filing with the FDA. The...
Kymera’s signals: pill reduces eczema while degrader shows biologic‑like biomarker activity
Kymera Therapeutics reported two early but impactful readouts: an oral candidate, KT‑621, produced a rapid clinical improvement in atopic dermatitis patients, and a separate STAT6 degrader program...
Structure surges: oral GLP‑1 pill posts up to 15% weight loss — tolerability debate looms
Structure Therapeutics reported mid‑stage data for its oral GLP‑1 candidate aleniglipron showing up to 15% placebo‑adjusted weight loss in Phase IIb cohorts, reviving investor interest in oral...
Wave’s RNA approach trims visceral fat and preserves muscle — early signals lift stock
Wave Life Sciences disclosed interim Phase 1 data showing its siRNA obesity candidate reduced visceral fat while maintaining or improving muscle mass markers, an outcome the company said compares...
BioNTech’s CTLA‑4 antibody improves survival — efficacy offsets tolerability concerns
BioNTech and OncoC4 reported Phase 3 survival data for their anti‑CTLA‑4 candidate that showed a large reduction in death risk in lung cancer, but subsequent analysis highlighted a challenging...
FDA sets higher bar for CAR‑T: superiority now expected — pivotal readouts test the claim
The FDA’s biologics chief argued in a journal article that new CAR‑T therapies will need to demonstrate superiority over existing standards to secure approval, signaling a tougher regulatory path...
KRAS G12D: more than 20 programs launch — companies race to drug common mutation
BioCentury reported an accelerating wave of programs targeting the KRAS G12D mutation, with more than 20 initiatives launched in the past year across biotech and Big Pharma. Companies are...
Medtronic’s Hugo RAS cleared by FDA — a new rival to da Vinci in soft‑tissue surgery
The U.S. FDA cleared Medtronic’s Hugo robotic‑assisted surgery (RAS) system, a regulatory milestone that gives the device maker a direct platform to challenge Intuitive Surgical’s da Vinci...