Scholar Rock Says FDA Review Of Apitegromab BLA Continues; Approval Decision Expected By Sept. 30

India, Aug. 7 -- Scholar Rock Holding Corp. (SRRK) said Friday the U.S. Food and Drug Administration will continue reviewing the Biologics License Application, or BLA, for apitegromab using the company's second fill-finish manufacturing facility, keeping the application on track for a potential approval decision by the September 30, 2026 PDUFA action date.

The company said it was notified that the FDA classified its April 2026 inspection of Catalent Indiana LLC, one of the two fill-finish facilities included in the original BLA, as Official Action Indicated, or OAI. Scholar Rock will remove Catalent Indiana from the application and proceed solely with its second U.S.-based fill-finish facility, which it said has demonstrated a strong compl...