Sarepta says eight-year-old death deemed unrelated to Elevidys

Sarepta (SRPT) said in a statement Friday night: “Just before 6:00 p.m. ET today, the U.S. Food and Drug Administration issued a press release announcing an investigation into the death of an eight-year-old Duchenne muscular dystrophy patient who had received Elevidys gene therapy. The death of this patient was deemed unrelated to treatment with Elevidys…Sarepta reported this event to FDA on June 18, 2025, via the FDA’s postmarketing electronic database, FAERS. At Sarepta, patient safety and well-being are always our top priority. We are committed to upholding the highest safety standards for all of our therapies, and do so in accordance with applicable law and commitment to full regulatory transparency. Elevidys is the only approved gene therapy for families and children devastated by Duchenne, a rare, progressive and ultimately fatal disease. We remain committed to working closely with the FDA to ensure that all decisions are grounded in science and the best interests of patients, considering the compelling need of these families to access disease-modifying therapy.”