Sarepta Resumes Select Gene Therapy Shipments Following FDA Recommendation

July 30, 2025

Sarepta Therapeutics resumed shipments of delandistrogene moxeparvovec-rokl (Elevidys), its gene therapy for ambulatory patients with Duchenne muscular dystrophy, following a recommendation from the Food and Drug Administration. An investigation by FDA and Brazilian health authorities concluded that the recent death of an 8-year-old boy in Brazil was unrelated to the gene therapy product.

Shipments of delandistrogene moxeparvovec-rokl for non-ambulatory patients remain on a voluntary hold while FDA investigates two other reports of patient mortality associated with the treatment.