Scholar Rock (SRRK) announced the FDA has accepted its Biologics License Application for apitegromab, an investigational muscle-targeted treatment that is being developed to provide clinically meaningful improvement in motor function for people living with spinal muscular atrophy who are receiving an SMN-targeted treatment. The FDA will review the application under priority review and has assigned a PDUFA target action date of September 22, 2025.
The company has also submitted and received validation for Marketing Authorisation Application to the European Medicines Agency for apitegromab for the treatment of SMA.
In anticipation of potential regulatory approvals, the company is planning for a U.S. commercial launch upon approval in 2025, with European launch anticipated in 2026.
Shares of Scholar Rock are up 3% in pre-market trade on Tuesday.
For More Such Health News, visit rttnews.com.
For comments and feedback contact: editorial@rttnews.com
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.