Scholar Rock’s Apitegromab Receives FDA Priority Review

Scholar Rock Holding ( (SRRK) ) just unveiled an update.

Scholar Rock announced its second quarter 2025 financial results and business updates, highlighting the FDA’s acceptance of the apitegromab Biologics License Application under priority review with a target action date of September 22, 2025. The company is preparing for a U.S. commercial launch upon approval and anticipates a European launch in 2026. Positive results from the Phase 2 EMBRAZE trial in obesity were reported, demonstrating the potential of apitegromab to preserve lean mass during weight loss. Scholar Rock’s financial position remains strong with $295 million in cash and marketable securities, expected to support operations into 2027.

The most recent analyst rating on (SRRK) stock is a Buy with a $30.00 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 apitegromab for patients with spinal muscular atrophy (SMA) and other severe and debilitating neuromuscular diseases. The company is a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily and has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions.

Average Trading Volume: 1,240,053

Technical Sentiment Signal: Strong Buy

Current Market Cap: $3.45B

For a thorough assessment of SRRK stock, go to TipRanks’ Stock Analysis page.