Scholar Rock surges after FDA to reinspect Catalent manufacturing site

Scholar Rock Holding

14/11/2025 14:42

** Shares of drug developer Scholar Rock SRRK.O rise 20.1% to $36.1

** Company says it had an in-person Type A meeting with the U.S. FDA, describing it as "constructive," a key step toward resubmitting its application for muscle weakness drug, apitegromab

** In September, the agency declined to approve   apitegromab citing issues at a third-party manufacturing facility

** The facility, Catalent Indiana, part of Novo Nordisk NOVOb.CO, confirmed remediation efforts are on track and expects its facility to be ready for reinspection by year-end, supporting SRRK's 2026 potential U.S. launch plans

** Scholar Rock says it has also accelerated timelines with an additional fill-finish facility that has a proven track record of successful site inspections

** Including session moves, stock down 30.4% YTD

 (Reporting by Siddhi Mahatole)

 ((siddhi.mahatole@thomsonreuters.com))