The FDA reversed its earlier decision and authorized Sarepta Therapeutics to resume shipments of Elevidys, its gene therapy for ambulatory Duchenne muscular dystrophy (DMD) patients, after concluding that a recent patient death was unrelated to the treatment. While shipments to younger, ambulant patients will recommence imminently, the voluntary pause on non-ambulatory patients remains in place pending further discussions. Sarepta supports ongoing FDA requests for enhanced safety labeling, including a black box warning for liver toxicity, following past adverse events linked to AAV-based therapies. This development provides some relief for patients and the company amid heightened safety scrutiny.