The FDA reversed its earlier hold and has authorized Sarepta Therapeutics to promptly resume shipments of Elevidys, its gene therapy for ambulatory Duchenne muscular dystrophy (DMD) patients. This reversal follows an investigation determining that the recent death of an 8-year-old patient in Brazil was unrelated to the therapy. Sarepta will maintain shipment holds for non-ambulatory patients while continuing safety label updates and further discussions with the FDA. The therapy's prior challenges included three fatalities linked to its use and regulatory scrutiny. Sarepta supports adding a black box warning for acute liver toxicity associated with Elevidys.