Sarepta Therapeutics is under intense scrutiny following multiple patient deaths associated with its Duchenne muscular dystrophy gene therapy, Elevidys. While initially pushing back on the FDA's halt request, Sarepta has now paused shipments amid safety concerns. The FDA reportedly plans additional studies to confirm Elevidys’ safety, potentially requiring new dosing or manufacturing adjustments rather than full trials. Meanwhile, European regulators have rejected Elevidys, citing lack of demonstrated functional benefit. The controversy has devastated patients’ families and shaken confidence in the treatment’s future.