Sarepta Therapeutics is embroiled in a regulatory crisis as the FDA has requested a voluntary halt to shipments of Elevidys, Sarepta's gene therapy for Duchenne muscular dystrophy (DMD), following patient deaths linked to acute liver failure. Sarepta initially refused the request, citing no new safety signals in ambulatory patients, but later reversed course to temporarily pause shipments to maintain a cooperative relationship with the FDA. Concurrently, ongoing Sarepta trials for limb-girdle muscular dystrophy were placed on FDA hold due to safety concerns, and the company’s gene therapy platform technology designation was revoked. This standoff has triggered significant stock declines and sparked debate in the biotech community regarding evidence standards for accelerated approvals.