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FDA raises bar for CAR‑T: New push for randomized superiority trials
The FDA signaled a policy shift that will require many developers of CAR‑T therapies to demonstrate superiority over existing treatments in randomized trials, according to statements from the...
Dyne’s exon‑51 program hits pivotal goals — Company plans expedited FDA submission
Dyne Therapeutics reported that its Duchenne muscular dystrophy exon‑51 exon‑skipping candidate met the primary endpoint in a pivotal study, producing statistically significant increases in...
Insilico’s AI‑designed PROTAC targets PKMYT1 — Preclinical activity reported
Insilico Medicine published preclinical data showing an AI‑designed proteolysis‑targeting chimera (PROTAC), D16‑M1P2, selectively degrades PKMYT1 and produced anti‑tumor activity in cell lines and...
Novartis inks $1.7B AI deal: Relation to hunt atopic targets
Novartis has signed a multi-program collaboration with London-based Relation Therapeutics to discover and advance targets for atopic diseases, the companies said. The deal includes an upfront...
Mirum buys Bluejay for $620M — wins hepatitis D antibody
Mirum Pharmaceuticals agreed to acquire Bluejay Therapeutics to secure brelovitug, a monoclonal antibody in late‑stage testing for chronic hepatitis D virus (HDV), the companies announced. The...
FDA raises bar: CAR‑T developers told to prove superiority
The FDA’s biologics leadership signaled a policy shift requiring many new CAR‑T applications to demonstrate superiority versus existing therapies, the agency’s guidance and commentary show....
Teclistamab+daratumumab: Majestec‑3 posts dramatic PFS gain
Data from the Majestec‑3 trial presented at ASH showed the combination of Janssen’s teclistamab and daratumumab produced an 83.4% three‑year progression‑free survival rate versus 29.7% for...
Terns’ TERN‑701 shakes up CML: 64% MMR at 24 weeks
Terns Pharmaceuticals reported early ASH data showing its next‑generation chronic myeloid leukemia candidate TERN‑701 achieved a 64% major molecular response rate at 24 weeks across four...
Kymera degrader signals biologic‑like activity; pill posts Dupixent‑style drop
Kymera reported Phase Ib biomarker activity for an oral STAT6 degrader and separately disclosed Phase 1b BroADen results for KT‑621, an oral pill for atopic dermatitis, that produced a mean 63%...
Dyne targets FDA: Duchenne exon‑51 drug hits pivotal endpoint
Dyne Therapeutics announced that its Duchenne muscular dystrophy candidate met the primary endpoint in a pivotal study and that the company plans to seek accelerated FDA approval. Company releases...
Oral GLP‑1 race heats: Structure posts double‑digit weight loss
Structure Therapeutics reported Phase IIb data showing its oral GLP‑1 candidate aleniglipron produced up to 15% weight loss in mid‑stage testing, while China’s Ascletis posted 7.7%...
AI designs PROTAC: Insilico reports PKMYT1 degrader; NeurIPS flags biology models
Insilico Medicine published a Nature Communications paper describing D16‑M1P2, an AI‑designed PROTAC that targets PKMYT1 and showed preclinical activity in CCNE1‑amplified and FBXW7‑mutant tumor...
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...