Sarepta Therapeutics reversed its previous refusal and agreed to temporarily pause shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy (DMD), following a request from the FDA. This follows three patient deaths linked to therapies using the same viral vector, including two involving Elevidys and one in an investigational limb-girdle muscular dystrophy (LGMD) trial. Sarepta aims to collaborate with FDA on safety labeling updates, including a black box warning for acute liver injury. The pause took effect shortly after a regulatory standoff that included clinical holds and public scrutiny over Sarepta’s disclosure practices.