The FDA is conducting a probe into the June death of an 8-year-old Brazilian boy who received Sarepta’s Elevidys gene therapy for Duchenne muscular dystrophy (DMD). The investigation follows two prior patient deaths linked to the therapy this year and prompted a voluntary suspension of Elevidys shipments in the U.S. Sarepta and Roche, the ex-U.S. rights holder, maintain the death was unrelated to treatment. Meanwhile, regulatory caution deepens as the European Medicines Agency’s committee recently recommended against approving Elevidys for young ambulatory patients. The safety concerns have triggered shipment pauses in several countries.