Scholar Rock Shares Rise After FDA Approves ISEMBYLD for Spinal Muscular Atrophy
Scholar Rock Holding Corp (NASDAQ:SRRK) shares rose by 9.1% in pre-market trading to $60.45 following the U.S. Food and Drug Administration's approval of its drug, ISEMBYLD, for spinal muscular atrophy. The treatment is now available for adults and children aged two years or older who are receiving an SMN2-targeted therapy. This marks a significant milestone as it becomes the first FDA-approved muscle-targeting therapy in this patient group. The approval was announced after market close on Friday ahead of its September 30, 2026 PDUFA deadline and triggered analysts to raise their price targets for Scholar Rock's stock. Truist Securities raised its target from $55 to $76 with a Buy rating; Raymond James increased it from $65 to $72 while maintaining a Strong Buy rating; Citi also raised its target, now at $74. Scholar Rock is preparing for the commercial launch of ISEMBYLD and has two fill-finish facilities in place. The company holds approximately $492 million in cash.
Tickers: $SRRK