Sarepta Therapeutics is grappling with regulatory and safety issues surrounding Elevidys, its gene therapy for Duchenne muscular dystrophy (DMD). The FDA requested a market withdrawal due to safety concerns amid patient deaths, prompting Sarepta to halt treatment distribution and conduct additional studies for reapproval. Roche, its marketing partner outside the U.S., has paused shipments in several countries but continues supplying ambulatory patients where approved independently of FDA. The developments have severely disrupted treatment access and led to substantial layoffs at Sarepta, raising concerns over the company’s near-term outlook.