Sarepta Therapeutics is under intensified regulatory scrutiny following the deaths of three patients linked to its gene therapies. The most recent fatality involved a 51-year-old man with limb girdle muscular dystrophy (LGMD) enrolled in the Phase I DISCOVERY trial of SRP-9004. This marks the third death this year associated with Sarepta's gene therapy vectors, prompting the FDA to request suspensions of Elevidys shipments. Sarepta rejected the FDA’s request, citing comprehensive safety data and expressing intent to continue access for ambulatory patients. Concurrently, all Sarepta's LGMD trials are on clinical hold amid the safety concerns, and the FDA revoked the company's gene therapy platform technology designation. The unfolding situation has significantly impacted Sarepta’s stock and cast uncertainty over its gene therapy pipeline.