Sarepta Faces Regulatory Showdown As Analysts Cut Price Targets
On Friday, the U.S. Food and Drug Administration placed Sarepta Therapeutics Inc.’s SRPT investigational gene therapy clinical trials for limb girdle muscular dystrophy (LGMD) on a clinical hold.The decision stemmed from serious safety concerns, including three patient deaths potentially linked to these products, indicating that study participants faced or would be exposed to an unreasonable and significant risk of illness or injury.The FDA also formally requested Sarepta to voluntarily halt all shipments o ...