FDA's Peter Marks Controversially Approves Sarepta's ($SRPT) Gene Therapy Elevidys

Jul 2, 2024, 01:05 PM

Peter Marks, a senior FDA official, made a controversial decision to approve Sarepta's ($SRPT) gene therapy, Elevidys, for Duchenne muscular dystrophy. The decision has sparked debate, as Marks overruled his staff and cited research from his critics, who called his interpretation 'misleading.' Despite the controversy, Duchenne providers largely supported the approval, although there were disagreements about its scope. The FDA has declined to answer questions regarding the precedents for Marks' decision.