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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...
Lilly acquires MeiraGTx eye program – expands genetic‑medicine footprint
Eli Lilly struck an agreement to obtain rights to an experimental ocular gene therapy from MeiraGTx, extending Lilly’s recent string of bets in genetic medicine. The deal gives Lilly rights to a...
Iambic raises more than $100M from ARK and Regeneron to push AI‑bio pipeline
Iambic Therapeutics closed a financing round exceeding $100 million with participation from ARK Invest and Regeneron, the San Diego biotech’s CEO told Endpoints. The cash infusion will accelerate...
Lilly bets up to $1.2B on Sanegene’s LEAD platform for metabolic RNAi
Eli Lilly entered a discovery‑stage collaboration with SanegeneBio that could generate up to $1.2 billion in milestone payments tied to Sanegene’s Ligand and Enhancer Assisted Delivery (LEAD)...
Pfizer clinches Metsera for $10B after bidding war with Novo Nordisk
Pfizer won a competitive acquisition for obesity drug developer Metsera with an up‑to‑$10 billion offer, outbidding Novo Nordisk and resolving a high‑stakes contest that had included litigation....
PACE panel presses for incentives as Ionis touts Tryngolza’s potential
At BIO 2025’s PACE patient advocacy event, industry and patient voices urged stronger incentives and policy protections for Genetically Targeted Technologies (GTTs), citing real‑world benefits...
Pfizer clinches Metsera for $10 billion – Bidding war ends
Pfizer agreed to acquire obesity‑drug developer Metsera in a deal valued at roughly $10 billion, outbidding Novo Nordisk and ending a high‑stakes auction. The offers centered on per‑share cash...
Lilly inks $1.2B pact with Sanegene – RNA delivery deal
Eli Lilly signed a discovery and option agreement with SanegeneBio centered on Sanegene’s LEAD (Ligand and Enhancer Assisted Delivery) platform for tissue‑selective RNAi therapeutics, with...
Merck’s oral PCSK9 pill delivers up to 60% LDL cuts – Phase 3 wins
Merck reported Phase 3 data showing its oral PCSK9 inhibitor produced LDL cholesterol reductions of up to 60% and achieved at least 50% LDL drops in roughly two‑thirds of participants. The trials...
Amgen’s Repatha prevents first heart attacks – VESALIUS‑CV confirms
Amgen released VESALIUS‑CV trial data showing its PCSK9 inhibitor Repatha reduced first‑time cardiovascular events by 25% and cut first heart attacks by 36% in high‑risk patients without prior...
CRISPR therapy slashes LDL and triglycerides in early human study
A CRISPR‑based gene editing therapy from CRISPR Therapeutics reported dramatic reductions in LDL cholesterol and triglycerides in an early human study, according to data presented at a major...
FDA halts Tenaya’s heart gene‑therapy trial over immunosuppression standardization
The FDA placed a clinical hold on Tenaya Therapeutics’ gene therapy study for heart disease while the company standardizes immunosuppression regimens across trial sites. Regulators requested...
Vir posts hepatitis D results, accelerates Phase 3 plans
Vir Biotechnology presented new data for its chronic hepatitis D combo regimen showing sustained viral suppression and supportive safety signals, and said pivotal trials are advancing ahead of...