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Roche’s BTK wins two phase 3s – MS program clears key hurdles
Roche reported two positive Phase 3 trials for its BTK inhibitor in multiple sclerosis, showing efficacy across relapsing disease and signals in primary progressive cohorts. The results mark a...
Cogent lines up NDAs after another Phase 3 win
Cogent Biosciences reported a Phase 3 victory for bezuclastinib in imatinib‑resistant gastrointestinal stromal tumors, halving the risk of progression or death versus sunitinib in the PEAK study...
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...