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Scholar Rock Faces FDA Setback for Apitegromab

Story Highlights
  • Scholar Rock’s FDA application for apitegromab was delayed due to issues at a third-party facility.
  • The delay affects the availability of a promising SMA treatment, with plans to resubmit once issues are resolved.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Scholar Rock Faces FDA Setback for Apitegromab

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The latest announcement is out from Scholar Rock Holding ( (SRRK) ).

On September 23, 2025, Scholar Rock announced that the FDA issued a Complete Response Letter (CRL) for their Biologics License Application (BLA) for apitegromab, a treatment for spinal muscular atrophy (SMA). The CRL was due to issues identified at Catalent Indiana LLC’s facility, unrelated to apitegromab’s efficacy or safety. Scholar Rock plans to resubmit the BLA once these manufacturing issues are resolved. The delay in approval has postponed the availability of this promising muscle-targeted treatment, which has shown potential in improving motor function in SMA patients. Apitegromab has received several designations from the FDA and EMA, highlighting its potential to address unmet medical needs in SMA.

The most recent analyst rating on (SRRK) stock is a Buy with a $45.00 price target. To see the full list of analyst forecasts on Scholar Rock Holding stock, see the SRRK Stock Forecast page.

Spark’s Take on SRRK Stock

According to Spark, TipRanks’ AI Analyst, SRRK is a Neutral.

Scholar Rock’s overall stock score reflects significant challenges due to financial underperformance, including a lack of revenue and ongoing losses. Despite these issues, positive strides in its SMA program and strategic leadership changes indicate potential for future growth. Mixed technical indicators and a weak valuation further moderate the outlook.

To see Spark’s full report on SRRK stock, click here.

More about Scholar Rock Holding

Scholar Rock is a late-stage biopharmaceutical company specializing in developing treatments for spinal muscular atrophy (SMA) and other rare neuromuscular diseases. The company leverages its expertise in myostatin biology to create innovative therapies aimed at improving musculoskeletal health.

Average Trading Volume: 1,646,635

Technical Sentiment Signal: Buy

Current Market Cap: $3.13B

Learn more about SRRK stock on TipRanks’ Stock Analysis page.

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