Scholar Rock resubmits BLA to FDA for apitegromab

Scholar Rock (SRRK) announced it has resubmitted the Biologics License Application, BLA, for apitegromab for the treatment of children and adults with Spinal Muscular Atrophy, SMA, to the U.S. Food and Drug Administration, FDA. The apitegromab BLA resubmission also includes a second U.S.-based fill-finish facility to strengthen the apitegromab supply chain and support future growing demand across the planned global commercial footprint. Following a positive Type C meeting on March 3, 2026, Scholar Rock aligned with the FDA to include the additional facility in the BLA resubmission based on the Company’s accelerated commercial fill-finish timelines. “Our apitegromab BLA resubmission marks an important step forward in our mission to bring the world’s first muscle-targeted therapy to children and adults living with SMA,” said David L. Hallal, Chairman and Chief Executive Officer of Scholar Rock. “We continue to be encouraged by the FDA’s engagement and shared sense of urgency as we work relentlessly for the SMA community. As we execute our plans for both Catalent Indiana and our second fill-finish facility, we look forward to anticipated apitegromab approvals and launches in both the U.S. and Europe this year.”