By Fineline Cube 
The U.S. Food and Drug Administration (FDA) has completed its investigation into the death of an 8-year-old boy who received Elevidys, an adeno-associated virus vector (AAV)-based gene therapy for Duchenne muscular dystrophy (DMD) developed by Sarepta Therapeutics and Roche (SWX: ROG, OTCMKTS: RHHBY). The investigation has determined that the death is unrelated to the gene therapy product itself.
Investigation Details
The death occurred on June 7, 2025. Following the incident, the FDA requested and received a voluntary suspension of Elevidys’ distribution to investigate safety concerns.
FDA’s Recommendation
After concluding its investigation, the FDA has recommended the removal of the voluntary hold for ambulatory patients. This decision means that eligible patients may now resume receiving Elevidys.-Fineline Info & Tech