Scholar Rock Holding Corp saw its stock advance 9.1% in pre-market trading to $60.45 following US Food and Drug Administration approval of ISEMBYLD (apitegromab-mstn) for treating spinal muscular atrophy. The medication was cleared for use in adults and children aged two years and older who are concurrently receiving an SMN2-targeted therapy. The company characterized ISEMBYLD as the first FDA-approved muscle-targeted treatment option for this patient demographic.
The regulatory decision came ahead of the September 30, 2026 PDUFA deadline and was announced following the close of trading. Multiple securities analysts responded to the approval by raising their price targets for the company. Truist Securities increased its target to $76 from $55 while maintaining a Buy rating, citing expectations regarding patient uptake rates. Raymond James raised its target to $72 from $65 and retained a Strong Buy rating, with projections for apitegromab revenue reaching approximately $2.2 billion by 2035. Citi also raised its price target to $74 from $60 while keeping a Buy rating in place.
The analyst community showed strong confidence in the company, with 18 Buy ratings and no Hold or Sell ratings among covered analysts. Scholar Rock shares traded near their 52-week high of $61.76 in the session following the pre-market increase, with the 52-week low standing at $27.07. The company reported approximately $492 million in cash and operates two independent fill-finish facilities as it transitions into the commercial phase for the newly approved treatment.
The stock’s gains occurred against a backdrop of weakness in broader equity markets, with the S&P 500 declining 0.7%, the Dow Jones falling 0.2%, and the Nasdaq down 1.7% during the session.
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