Scholar Rock Shares Jump as Apitegromab BLA Resubmitted to FDA for SMA Treatment
Scholar Rock resubmits its BLA for apitegromab to treat SMA. FDA acceptance expected in 30 days, PDUFA target late September 2026.
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Lilly Signs $2.75B AI Drug Deal with Hong Kong’s Insilico Medicine
Eli Lilly has signed a $2.75 billion deal with Hong Kong-listed AI biotech Insilico Medicine for a GLP-1 diabetes drug.
Lilly’s Retatrutide Crushes Weight Loss Goals in First Phase 3 Trial – Wall Street Says It’s a ‘Key Pillar’ for Growth
Eli Lilly’s retatrutide delivered up to 2.0% A1C reduction and 16.8% weight loss (36.6 lbs) in its first Phase 3 trial for type 2 diabetes. Analysts call it a key growth driver for Lilly with strong results vs Mounjaro.
Novo Nordisk Faces More Pain: Bernstein Initiates Underperform Coverage
Bernstein initiates Underperform on Novo Nordisk, citing endless earnings downgrades, weak catalysts, U.S. price deflation, and 2032 patent cliff risks.
Structure Therapeutics' Oral Obesity Pill Aleniglipron Hits Record 16.3% Weight Loss in Phase 2 Trial – Matches Injectables with No Plateau
Structure Therapeutics' oral pill aleniglipron achieved 15–16% body weight loss (up to 39 lbs) after 44 weeks in Phase 2, rivaling injectables with better tolerability and no plateau. Phase 3 is planned for 2026—a potential game changer for obesity treatment.
FDA Issues Warning Letter to Novo Nordisk Over Delayed Safety Reports for Ozempic and Victoza
Novo Nordisk receives FDA warning letter after 2025 Plainsboro inspection revealed failures in timely reporting serious side effects for drugs like Ozempic and Victoza. Company says no impact on production.