SRRK PDUFA date: FDA decision expected September 30, 2026

The FDA is expected to decide on this application from Scholar Rock Holding Corporation by the PDUFA target action date of September 30, 2026. Scholar Rock has a PDUFA decision date in September 2026 for a new treatment targeting SMA patients. The announcement indicates regulatory progress for the company's therapeutic candidate.

A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.