The FDA has permitted Sarepta Therapeutics to resume shipments of its gene therapy Elevidys for ambulatory patients with Duchenne muscular dystrophy (DMD) following an investigation that concluded a recent patient death was unrelated to the treatment. This reverses a prior voluntary hold on the therapy after two earlier fatalities linked to the drug raised safety concerns. Sarepta will continue pausing shipments to non-ambulatory patients as discussions about risk mitigation remain ongoing. The agency has also requested Sarepta to update the drug’s labeling to include a black box warning for serious liver-related adverse events. This regulatory back-and-forth has triggered market volatility and raised questions about the FDA’s decision-making processes on advanced gene therapies.