Scholar Rock's ISEMBYLD Wins FDA Approval As First Muscle-Targeted Therapy For SMA

Scholar Rock (SRRK) shares rose 9.1% to $60.45 after FDA approved ISEMBYLD for spinal muscular atrophy. The treatment targets adults and children aged 2+ on SMN2-targeted therapy. Analysts raised price targets, with Truist, Raymond James, and Citi citing strong potential. SRRK has $492M in cash and prepares for commercial launch.

Scholar Rock Holding Corp (SRRK) stock rose 9.1% to $60.45 after the FDA approved its drug ISEMBYLD for spinal muscular atrophy. Analysts raised price targets, with Truist Securities at $76, Raymond James at $72, and Citi at $74, citing strong revenue potential. The company has $492 million in cash and is ready to commercialize the drug.

Scholar Rock (SRRK) shares rose 2% after removing a Novo Nordisk-owned plant from its FDA application for apitegromab, addressing previous rejection reasons. The company expects a decision by September 30 and is ready to launch if approved. SRRK stock is up 28% year-to-date.

Scholar Rock received FDA approval for Isembyld, a treatment for spinal muscular atrophy. The therapy is the first of its kind and showed significant improvement in motor function. Shares rose 23% in after-market trading. Analysts project peak sales of $2.1 billion by 2035, according to BMO Capital Markets.

Scholar Rock's (SRRK) Isembyld, a drug for spinal muscular atrophy, received FDA approval. The company plans an immediate U.S. launch and seeks approval in Europe and Japan. SRRK stock rose 15% after-hours. Isembyld is the first SMA treatment targeting muscle loss, showing efficacy in clinical trials.

FDA approved Scholar Rock's Isembyld for muscle loss in SMA patients aged 2+ already on SMN2-targeting therapy. Clinical trial showed significant motor skill improvement in treated group vs. placebo. CEO called it a breakthrough.