Scholar Rock’s BLA for Apitegromab Accepted by FDA

Scholar Rock Holding ( (SRRK) ) has shared an announcement.

Scholar Rock announced its first quarter 2025 financial results and significant progress in its business operations. The FDA has accepted the Biologics License Application (BLA) for apitegromab under priority review for SMA, with a target action date set for September 22, 2025. The European Medicines Agency has also validated the Marketing Authorisation Application, anticipating a European launch in 2026. The company is preparing for a U.S. commercial launch in 2025 and has strengthened its leadership team to support this transition. Financially, Scholar Rock reported a net loss of $74.7 million for the quarter, with increased expenses attributed to commercial readiness and development activities.

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 therapies for spinal muscular atrophy (SMA) and other severe neuromuscular diseases. The company is advancing its pipeline of innovative treatments, including apitegromab, a monoclonal antibody targeting myostatin activation in skeletal muscle, and exploring additional applications in neuromuscular disorders and cardiometabolic conditions.

Average Trading Volume: 1,224,901

Technical Sentiment Signal: Buy

Current Market Cap: $3.08B

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