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FDA places hold on Tenaya’s heart‑gene trial over immunosuppression standardization
The FDA issued a clinical hold on a Tenaya Therapeutics gene therapy trial while the company standardizes immunosuppression protocols across study sites. Tenaya said it is addressing the agency’s...
Iambic raises $100M to advance AI‑discovered therapeutics and platform
Iambic Therapeutics closed an oversubscribed financing of over $100 million, backed by investors including ARK, Regeneron Ventures and Illumina Ventures to accelerate its pipeline of AI‑discovered...
Ultrasound clears intracranial debris and improves recovery in hemorrhagic stroke models
A study published in Nature Biotechnology showed therapeutic ultrasound clears intracranial debris after hemorrhagic stroke in mice, reducing inflammation and improving neurological recovery. The...
Pfizer wins Metsera — $10 billion obesity deal sealed
Pfizer agreed to acquire Metsera in a deal valued at about $10 billion after rival Novo Nordisk declined to increase its bid. The transaction secures Metsera’s clinical and preclinical obesity...
Merck’s oral PCSK9 pill: injectable-like LDL cuts reported
Merck presented pivotal data showing its oral PCSK9 candidate produced LDL-cholesterol reductions comparable to injectable PCSK9 inhibitors. In analyses reported at the American Heart Association,...
Roche’s BTK inhibitor posts Phase 3 wins — multiple sclerosis filings ahead
Roche reported two Phase 3 victories for its BTK inhibitor in multiple sclerosis, clearing the primary objectives in separate registrational studies. One trial showed non-inferiority to...
Cogent’s bezuclastinib halves progression risk — NDAs in view
Cogent Biosciences announced Phase 3 success for bezuclastinib in imatinib-resistant or -intolerant gastrointestinal stromal tumors (GIST), reporting a median progression-free survival of 16.5...
Lilly expands Insilico pact — AI moves from software to drug discovery
Eli Lilly upgraded its relationship with Insilico Medicine, converting a prior software licensing arrangement into a joint drug-discovery partnership. The companies disclosed the collaboration...
Lilly signs $1.2B RNAi pact with Sanegene — tissue-selective delivery in play
Eli Lilly entered a discovery and option collaboration with Suzhou Sanegene Bio centered on Sanegene’s Ligand and Enhancer Assisted Delivery (LEAD) tissue‑selective RNAi technology. The agreement...
Lilly buys MeiraGTx retinal program — $75 million upfront for LCA4 gene therapy
Eli Lilly acquired global rights to MeiraGTx’s AAV‑AIPL1 gene therapy for Leber congenital amaurosis 4 (LCA4) for $75 million up front. The program is on track for U.S. and European regulatory...
FDA puts Tenaya trial on hold — immunosuppression regimen under review
The U.S. Food and Drug Administration placed a clinical hold on Tenaya Therapeutics’ gene-therapy study for heart disease while the company standardizes immunosuppression procedures across trial...
Researchers build phages with synthetic genomes — gene‑by‑gene editing unlocked
Teams led by Graham Hatfull and collaborators constructed bacteriophages with fully synthetic genomes, creating a platform that allows researchers to add, remove and edit genes modularly. The...
Two mid‑stage misses: Anaptys abandons UC; Neurocrine sees depression program fail
AnaptysBio announced its rosnilimab Phase 2 ulcerative colitis trial failed to meet primary and key secondary endpoints; the company will discontinue the UC program and redirect resources toward...
Pfizer clinches Metsera: $10 billion deal ends Novo challenge
Pfizer secured Metsera after a competitive week-long auction, matching an up-to-$10 billion offer and prompting Novo Nordisk to stand down. The amended merger agreement transfers Metsera’s obesity...
Merck pill rivals injectables: LDL down nearly 60%
Merck presented pivotal Phase 3 data showing its oral PCSK9 inhibitor reduced LDL cholesterol by about 59.7% versus placebo in key trials presented at the American Heart Association. The CORALreef...
Cogent soars: Phase 3 shows bezuclastinib halves progression risk
Cogent Biosciences reported Phase 3 success for bezuclastinib in imatinib‑resistant or intolerant gastrointestinal stromal tumors (GIST), showing median progression‑free survival of 16.5 months...
Lilly nabs MeiraGTx retinal program: $75M up front
Eli Lilly acquired global rights to MeiraGTx’s AAV‑AIPL1 gene therapy for Leber congenital amaurosis 4 (LCA4), paying $75 million up front and taking on programs expected to file for U.S. and...
Iambic raises $100M+ — AI drug discovery keeps attracting capital
Iambic closed an oversubscribed financing round raising more than $100 million from a broad investor base including ARK and Regeneron Ventures. The San Diego AI‑driven biotech said it will use...
AAVantgarde banks $141M — pivots to Stargardt and Usher1B trials
AAVantgarde raised $141 million in a Series B round co‑led by Schroders Capital alongside Atlas Venture and Forbion to advance two pivotal programs targeting inherited retinal diseases. The...
Lilly inks $1.2B pact with Sanegene — tissue‑targeted RNA push
Eli Lilly struck a discovery and option agreement with SanegeneBio valued up to $1.2 billion in potential biobucks to leverage Sanegene’s Ligand and Enhancer Assisted Delivery (LEAD) platform for...