Scholar Rock Shares Rise 9.1% After FDA Approves ISEMBYLD for Spinal Muscular Atrophy

Scholar Rock Holding Corp (NASDAQ:SRRK) shares rose 9.1% in pre-market trading to $60.45 after the US Food and Drug Administration approved ISEMBYLD (apitegromab-mstn) for the treatment of spinal muscular atrophy.

The treatment was approved for adults and children aged two years and older who are receiving an SMN2-targeted therapy. According to the supplied information, ISEMBYLD is the first FDA-approved muscle-targeted treatment for this patient population.

The approval was announced after Friday's market close and came ahead of the September 30, 2026 PDUFA deadline.

Analysts Raise Scholar Rock Price Targets

Several analysts increased their price targets following the FDA decision.

Truist Securities raised its target to $76 from $55 and maintained a Buy rating, citing expectations for patient uptake. Raymond James increased its target to $72 from $65 and retained a Strong Buy rating, with its analysts forecasting apitegromab revenue of approximately $2.2 billion by 2035.

Citi raised its price target to $74 from $60 while maintaining a Buy rating.

According to the supplied data, Scholar Rock currently has 18 Buy ratings and no Hold or Sell ratings among analysts covering the company.

The FDA approval moves Scholar Rock into the commercial stage as it prepares to launch ISEMBYLD.

The company has two independent fill-finish facilities and approximately $492 million in cash, according to the supplied information.

Scholar Rock shares were trading close to their 52-week high of $61.76 following Monday's pre-market advance. The stock's 52-week low stands at $27.07.

Scholar Rock's advance came during a weaker session for US equities. The S&P 500 declined 0.7%, the Dow Jones fell 0.2% and the Nasdaq was down 1.7%.

The company's pre-market move followed the FDA approval and subsequent increases in analyst price targets.