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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...
FDA puts Tenaya trial on hold: standardize immunosuppression across sites
The FDA placed a clinical hold on Tenaya Therapeutics’ heart disease gene therapy trial, requesting the company standardize immunosuppression procedures across participating sites. Tenaya must...
Medicare covers Personalis MRD assay — surveillance for stage II–III breast cancer
The Centers for Medicare & Medicaid Services granted coverage for Personalis’ NeXT Personal minimal residual disease (MRD) test for recurrence monitoring in Medicare beneficiaries with stage II...
Ultrasound clears brain debris... boosts recovery in hemorrhagic stroke models
Nature Biotechnology published preclinical studies showing focused ultrasound cleared intracranial debris in mouse models of hemorrhagic stroke, reduced inflammation, and improved functional...
Merck’s oral PCSK9 pill posts near-injectable LDL cuts: pivotal readouts
Merck reported pivotal Phase 3 data showing its oral PCSK9 inhibitor, enlicitide, produced LDL-C reductions comparable to injectable PCSK9 inhibitors. The company presented re‑analysed results at...
Roche’s BTK wins clear registrational bar: two Phase 3 victories
Roche announced two Phase 3 successes for its BTK inhibitor fenebrutinib in different multiple sclerosis populations, clearing registrational endpoints after a wave of earlier failures in the...
China clears sequencing‑based pan‑solid tumor CDx: Geneseeq gains NMPA nod
Geneseeq received marketing authorization from China’s National Medical Products Administration for its PanTRKare NTRK fusion detection kit as a companion diagnostic for Roche’s Rozlytrek...
Medicare covers Personalis MRD test for breast cancer surveillance
Personalis announced that the US Centers for Medicare & Medicaid Services will cover its NeXT Personal minimal residual disease (MRD) test for surveillance of stage II–III breast cancer in...
CRISPR editing cuts cholesterol and triglycerides in early trial — AHA data
Data presented at the American Heart Association meeting showed an early‑stage CRISPR Therapeutics gene‑editing therapy significantly reduced cholesterol and triglyceride levels in trial...
AAVantgarde raises $141M to advance retinal gene programs
Italian gene‑therapy developer AAVantgarde closed a $141 million Series B to support two pivotal clinical programs targeting inherited retinal diseases, with new and returning investors including...
AI‑drug developer Iambic scores $100M+ to advance platform and candidates
Iambic, an AI‑driven drug discovery company, raised over $100 million in an oversubscribed financing round led by institutional and strategic investors including ARK and Illumina Ventures. The...