Sarepta Therapeutics' Duchenne muscular dystrophy gene therapy Elevidys remains embroiled in controversy following its FDA accelerated approval in June 2023. The therapy, priced at $3.2 million, has been linked to the deaths of two teenage boys, prompting the FDA to request a shipment halt in July. Sarepta initially resisted but later complied. The events have caused significant distress to the DMD community, with treatment appointments postponed indefinitely. Regulatory officials have indicated Sarepta will need new safety studies to regain market access. Elevidys aims to replace dystrophin protein but faced skepticism due to limited efficacy evidence.