Scholar Rock Holding shares surge 10.07% intraday after resubmitting Apitegromab BLA for SMA and enhancing supply chain with new facilities.

Scholar Rock Holding surged 10.07% intraday, driven by its announcement to resubmit the BLA for Apitegromab to the FDA for the treatment of spinal muscular atrophy (SMA) in children and adults. The resubmission, expected to be accepted within 30 days, sets a PDUFA action date in late September 2026. The BLA includes manufacturing support from Catalent Indiana and a second U.S. fill-finish facility, aligning with FDA guidance from a March 3 Type C meeting and strengthening its supply chain strategy.