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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...
FDA halts Tenaya gene‑therapy trial over immunosuppression inconsistencies
The US Food and Drug Administration placed a clinical hold on Tenaya Therapeutics’ gene‑therapy study for a heart disease indication, citing the need to standardize immunosuppression regimens...
Lilly doubles down on genetic and RNA strategies: deals with MeiraGTx and Sanegene
Eli Lilly struck two strategic deals to expand its genetic‑medicine footprint: a partnership with SanegeneBio worth up to $1.2 billion in milestones to discover tissue‑targeted RNAi therapeutics...
AnaptysBio abandons rosnilimab for ulcerative colitis after Phase 2 failure
AnaptysBio said it will discontinue development of PD‑1 agonist rosnilimab in ulcerative colitis after a Phase 2 study missed primary and key secondary endpoints; remission rates at week 12 were...
Roche’s BTK inhibitor: Two Phase 3 wins in multiple sclerosis
Roche announced two positive registrational Phase 3 readouts for its BTK inhibitor fenebrutinib across different forms of multiple sclerosis. The Swiss drugmaker said one study met its primary...
Merck’s PCSK9 pill cuts LDL up to 60% — Phase 3 readout
Merck reported Phase 3 data showing its oral PCSK9 inhibitor produced LDL cholesterol reductions up to 60% in patients already on statins, fulfilling a long‑standing industry goal of an oral...
Amgen’s Repatha prevents first heart attacks — NEJM and AHA data
Amgen presented and published pivotal VESALIUS‑CV data showing its PCSK9 monoclonal antibody Repatha reduced first‑time cardiovascular events by about 25% in high‑risk patients without prior heart...
CRISPR gene editing trims LDL and triglycerides in early human study
An early‑phase CRISPR‑based gene editing therapy produced substantial reductions in LDL cholesterol and triglycerides in a small cohort of patients, investigators reported. The preliminary...
FDA places Tenaya’s heart gene therapy on clinical hold
The FDA has placed a clinical hold on Tenaya Therapeutics’ cardiac gene therapy trial while the company standardizes immunosuppression practices across participating sites, the agency and company...