Sarepta Shares Jump After FDA Approves Updated Elevidys Label

Core Viewpoint - Sarepta Therapeutics, Inc. experienced a stock price increase following the FDA's issuance of a new boxed warning for its gene therapy Elevidys, which is now restricted to specific patient groups due to safety concerns [1][2]. Summary by Sections FDA Warning and Approval Changes - The FDA added a Boxed Warning to Elevidys, indicating a high level of safety concern due to reports of fatal liver injuries in non-ambulatory pediatric patients [1][5]. - Elevidys is now approved only for ambulatory patients aged four or older with a confirmed Duchenne muscular dystrophy (DMD) gene mutation [2][5]. Safety Concerns and Patient Cases - Reports indicated that affected children experienced severely increased liver enzymes and required hospitalization within two months of treatment [3]. - A serious non-fatal liver injury case involved complications such as mesenteric vein thrombosis, bowel damage, tissue death, and portal hypertension [3]. Stock Performance - Sarepta's stock has declined nearly 50% over the past six months, but it rose by 5.56% to close at $18.81 following the FDA announcement [3].