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Scholar Rock Faces FDA Warning, Plans 2026 Launch

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Scholar Rock Faces FDA Warning, Plans 2026 Launch

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

On October 10, 2025, Scholar Rock Holding Corporation was informed by Catalent Indiana, part of Novo Nordisk, about an FDA warning letter following a July 14, 2025 inspection. Despite this, Scholar Rock anticipates resubmitting its biologics license application and launching apitegromab for spinal muscular atrophy in the U.S. in 2026, pending FDA approval.

The most recent analyst rating on (SRRK) stock is a Buy with a $47.00 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 Holding Corporation operates in the biotechnology industry, focusing on the development of innovative biologic therapies for serious diseases, with a particular emphasis on spinal muscular atrophy.

Average Trading Volume: 2,624,669

Technical Sentiment Signal: Buy

Current Market Cap: $4.28B

For detailed information about SRRK stock, go to TipRanks’ Stock Analysis page.

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