Eye Doctor and Fox News Regular Eyed as New Head of FDA Vaccine Division
FDA may pick Dr. Hemmati to lead CBER, which could speed up vaccine and biotech drug approvals, but decision is not final.
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Sarepta Hits Early Win With New siRNA Drugs for Rare Muscle Diseases – Beating Rivals on Delivery and Safety
Sarepta just shared first test results for two new medicines aimed at rare muscle diseases FSHD1 and DM1. Early data show the drugs reach high levels in muscle safely, with no serious side effects. Shares jumped.
Solid Biosciences Gets Wall Street Boost: Guggenheim Initiates Buy, Cites Advantage Over Sarepta in DMD
Guggenheim starts SLDB coverage with Buy rating and $26 price target. SGT-003 gene therapy shows safer profile vs Sarepta's Elevidys, eyes accelerated FDA approval.
Vinay Prasad Leaves FDA After High-Profile Clashes Over Gene Therapies
Dr. Vinay Prasad, head of the FDA's vaccines and biologics division, is stepping down at the end of April after a controversial year overseeing approvals for vaccines, gene therapies, and biotech products.
Wall Street Bears Circle Sarepta: Sell Ratings Pile Up After Q4 Reset Warnings
Major analysts like Citi, Needham, and Bank of America maintain Sell ratings on Sarepta after recent updates, citing risks to key products like Elevidys, lower 2026 outlook, and regulatory concerns in Duchenne muscular dystrophy treatments.
Sarepta's Elevidys Gene Therapy Shows Lasting Benefits Three Years After Treatment for Duchenne Muscular Dystrophy
Sarepta Therapeutics reports positive three-year results for Elevidys gene therapy in Duchenne patients, showing 70% slowing of disease progression and sustained motor function improvements, boosting investor confidence.