Sarepta Therapeutics is facing a major regulatory challenge as the FDA prepares to request a halt on shipments of its Elevidys gene therapy for Duchenne muscular dystrophy following multiple patient deaths attributed to acute liver failure. The company has also reported a fatality in its experimental limb-girdle muscular dystrophy gene therapy program. Sarepta disputes the FDA's request to stop Elevidys shipments and remains engaged in discussions to maintain patient access. These developments have triggered significant stock volatility and widespread concern within the gene therapy field.