Sarepta Therapeutics clarified that two patient deaths reported in the FDA Adverse Event Reporting System (FAERS) related to Elevidys, its gene therapy for Duchenne muscular dystrophy, were unrelated to treatment. These cases involved complications such as pneumothorax and viral infection but differed from previously reported liver failure deaths. Sarepta resumed shipments to ambulatory patients and continues to monitor safety profiles closely. FAERS statistics show 168 reports with 105 serious events as of mid-2024, though causal links to Elevidys remain under FDA review, indicating ongoing pharmacovigilance in this emerging gene therapy space.