REGENXBIO Q1 Earnings: Revenue Miss Overshadows Positive Duchenne Gene Therapy Data
Regenxbio’s DMD gene therapy showed strong results, boosting muscle protein and safety, moving closer to FDA approval.
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Sarepta Therapeutics Q1 2026 Earnings: Big Beat, But Stock Still Falls
Sarepta reported strong Q1 2026 earnings, with revenue of $730.8M, but shares fell as Elevidys sales dropped 46% due to label restrictions.
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.
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.