Scholar Rock Announces FDA Priority Review Designation For Apitegromab - Quick Facts

(RTTNews) - 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.

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