Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, today issued the following statement in response to an FDA announcement regarding the reported death of an eight-year-old patient with Duchenne muscular dystrophy (Duchenne) who had received gene therapy treatment with ELEVIDYS (delandistrogene moxeparvovec): Shortly before 6:00 p.m. ET today, the U.S. Food and Drug Administration (FDA) released a statement acknowledging an investigation into the incident. Importantly, the death was assessed as unrelated to treatment with ELEVIDYS. This aligns with information reported earlier by Bloomberg News, where Roche Holding AG – Sarepta’s international partner for ELEVIDYS – confirmed that the child in Brazil was not a clinical trial participant and that the reporting physician had determined no link between the therapy and the tragic event. The incident was duly reported to health authorities, and Roche has respectfully declined to release further personal details. Sarepta had proactively reported the case to the FDA on June 18, 2025, via the FDA’s postmarketing safety database (FAERS), in accordance with regulatory protocol. “At Sarepta, the safety and well-being of patients and their families are at the heart of everything we do,” said a company spokesperson. “We uphold the highest clinical and ethical standards across all our programmes and are committed to complete transparency with global regulatory agencies.” ELEVIDYS is currently the only FDA-approved gene therapy for Duchenne muscular dystrophy—a rare, relentlessly progressive, and ultimately fatal disease that affects thousands of children worldwide. Sarepta remains unwavering in its mission to deliver life-changing therapies and will continue to collaborate closely with the FDA to ensure all decisions are driven by scientific rigour, data integrity, and the urgent needs of the Duchenne community.