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FDA approvals and label moves
The FDA has approved Rocket Pharmaceuticals’ Kresladi (marnetegragene autotemcel) as the first gene therapy for severe leukocyte adhesion deficiency type I (LAD-I), granting accelerated approval...
EU regulatory actions
The European Medicines Agency’s CHMP recommended four new medicines in March and issued a label outcome for multiple indications. CHMP backed extended options for extended-stage small cell lung...
M&A and major dealmaking
Otsuka moved to acquire Transcend Therapeutics in a deal valued at about $1.2 billion, including a $700 million upfront payment and potential additional milestones. The transaction would bring...
Oncology deals and pipeline consolidation
Merck is set to acquire Terns Pharmaceuticals in an all-cash $6.7 billion transaction, aiming to bolster its oncology portfolio with TERN-701. The bid values Terns at $53 per share and is expected...
Immunology and allergy M&A
Novartis agreed to acquire Excellergy for up to $2 billion in upfront and milestone payments, adding Excellergy’s next-generation anti-IgE effector cell response inhibitor (ECRI) concept to its...
Clinical data catalysts in respiratory disease
AstraZeneca reported Phase 3 success for tozorakimab (a systemic IL-33-blocking antibody candidate) across two COPD trials, Oberon and Titania. The program met its main goal in a...
Rare disease and immune therapy risk signals from regulators or science
A PUPER perfusion device called “Mother” preserved a donated human uterus outside the body for the first time, keeping the organ alive for one day using modified blood in a perfusion system...
Wave obesity program setback drives market repricing
Wave Life Sciences’ obesity update triggered a sharp market reaction after data suggested limited incremental efficacy from higher doses of its INHBE-targeted siRNA candidate, WVE-007. The update...
Drug delivery and implantable “living pharmacy” platforms
Northwestern University led progress toward implantable “living pharmacies,” reporting a wireless, fully implantable biohybrid system designed to keep engineered cells alive long enough to produce...
Biomarkers and diagnostics for cancer detection
Maryland awarded more than $520,000 to fire departments to deploy a multi-cancer early detection (MCED) screening program using 20/20 BioLabs’ OneTest blood assay. The funding will support testing...
Alzheimer’s drug candidate
Researchers are putting a long-known acetylcholinesterase inhibitor lineage back into the spotlight with buntanetap, a modern derivative of physostigmine, now in Alzheimer’s disease clinical...
Regulatory approvals: rare disease gene therapy
The FDA granted accelerated approval to Rocket Pharmaceuticals’ gene therapy Kresladi (marnetegragene autotemcel) for severe leukocyte adhesion deficiency type I (LAD-I), marking the first gene...
Regulatory approvals: EMA label decisions
The European Medicines Agency’s CHMP recommended approval of four new medicines in March and also supported two existing FDA-approved therapies for extended-stage small cell lung cancer, while...
Dealmaking: Otsuka-Transcend psychiatric acquisition
Otsuka moved to deepen its neuropsychiatry portfolio through a $700 million upfront acquisition of Transcend Therapeutics (deal value roughly $1.2 billion including milestones). Otsuka plans to...
Dealmaking: Novartis allergy expansion
Novartis agreed to acquire Excellergy, a next-generation anti-IgE biotech, in a transaction valued at up to $2 billion in upfront and milestone payments. The deal is designed to extend Novartis’...
M&A: Merck pushes oncology with Terns bid
Merck (MSD) announced a $6.7 billion all-cash acquisition offer for Terns Pharmaceuticals, including $53 per share consideration and closing expected in the second quarter of 2026 subject to...
Clinical progress: COPD antibody Phase 3 win
AstraZeneca reported Phase 3 success for tozorakimab (IL-33 antibody) in COPD trials Oberon and Titania, with results meeting the main goal in both studies across broader patient populations than...
Clinical development: ocular gene/antibody progress in diabetic retinopathy
Kodiak’s tarcocimab tedromer program, branded as Zenkuda, delivered a Phase 3 win in diabetic retinopathy in the Glow2 trial, beating a sham procedure. The company plans to move quickly toward an...
Clinical trial data: gut-immune mechanism in multiple sclerosis
A Keio University-led study linked intestinal epithelial cell signaling to the initiation of neuroinflammation in multiple sclerosis models. Researchers reported in Science Immunology that...
Funding: Pinnacle raises for oral peptide pipeline
Pinnacle Medicines raised $89 million in a Series B to advance its oral peptide programs, pushing total capital raised to $134 million. The round was co-led by LAV and Foresite Capital, with...