Sarepta Faces Regulatory Showdown As Analysts Cut Price Targets

Group 1 - The U.S. FDA has placed Sarepta Therapeutics Inc.'s SRPT investigational gene therapy clinical trials for limb girdle muscular dystrophy (LGMD) on clinical hold due to serious safety concerns, including three patient deaths potentially linked to the products [1] - The FDA has requested Sarepta to voluntarily halt all shipments of Elevidys, the company's approved gene therapy, but Sarepta has refused this request [2] - Analysts from Needham have downgraded Sarepta from Hold to Underperform, expressing concerns that the FDA's feedback puts Elevidys' future in jeopardy and may challenge the company's ability to meet its 2027 debt obligations [3][4] Group 2 - William Blair views the FDA's announcement as a worst-case scenario for Sarepta, potentially affecting patient interest in Elevidys and indicating a fractured relationship with the FDA [5] - William Blair maintains a Market Perform rating for Sarepta, suggesting that Elevidys will not be formally withdrawn from the market, but anticipates a delayed BLA submission for SRP-9003 and lower commercial adoption of Elevidys [6] - Other analysts have also downgraded Sarepta, with Mizuho lowering the price forecast from $40 to $14, and Piper Sandler reducing it from $32 to $18 [7]