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Scholar Rock Holds Constructive FDA Meeting for Apitegromab

Story Highlights
  • Scholar Rock held a Type A meeting with the FDA for apitegromab and plans a 2026 U.S. launch.
  • The company reported a $102.2 million net loss but expects cash reserves to fund operations into 2027.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Scholar Rock Holds Constructive FDA Meeting for Apitegromab

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Scholar Rock Holding ( (SRRK) ) has provided an update.

Scholar Rock reported its third quarter 2025 financial results and recent business highlights, including a constructive Type A meeting with the FDA for its apitegromab biologics license application. The company anticipates resubmitting the BLA and launching apitegromab in the U.S. in 2026, with accelerated timelines due to an additional fill-finish facility. Scholar Rock is also progressing with its Phase 2 OPAL study and plans to initiate clinical development for a second neuromuscular disorder by the end of 2025. Financially, the company reported a net loss of $102.2 million for the quarter, with cash reserves expected to fund operations into 2027.

The most recent analyst rating on (SRRK) stock is a Buy with a $49.00 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 focused on developing and commercializing treatments for spinal muscular atrophy (SMA) and other rare, severe neuromuscular diseases. The company is a leader in myostatin biology, aiming to improve musculoskeletal health through innovative monoclonal antibodies.

Average Trading Volume: 2,516,271

Technical Sentiment Signal: Buy

Current Market Cap: $2.96B

See more data about SRRK stock on TipRanks’ Stock Analysis page.

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