Sarepta Therapeutics faces a crisis following the deaths of three patients linked to its gene therapies for Duchenne muscular dystrophy and limb-girdle muscular dystrophy. The fatalities, caused by acute liver failure, have prompted Sarepta to pause shipments of the Duchenne treatment Elevidys for most patients and sparked an FDA request to halt all Elevidys shipments entirely. The FDA is investigating liver safety concerns, weighing potential market withdrawal. Sarepta CEO Douglas Ingram defended the company's transparency despite criticism over delayed disclosures. Sarepta's refusal to comply with the FDA's halt request indicates escalating regulatory tension as stakeholders grapple with gene therapy risks.