Sarepta Therapeutics is under intense regulatory scrutiny as the FDA halted shipments of its Duchenne muscular dystrophy gene therapy Elevidys in several countries and called for new studies to demonstrate safety. The company experienced adverse patient events and halted US distribution following safety concerns. The ongoing situation has caused significant emotional distress among affected families and has led to workforce reductions at Sarepta and partner Arrowhead Pharmaceuticals, though the latter maintains confidence in Sarepta’s financial commitments. Regulatory and market uncertainty cloud Sarepta’s near-term outlook.