NasdaqGS:SRRKBiotechs
FDA Manufacturing Letter And Backup Plant Plans Could Be A Game Changer For Scholar Rock (SRRK)
Earlier in 2025, Scholar Rock Holding reported that the Novo Nordisk Bloomington, Indiana site (formerly Catalent Indiana LLC) received an FDA warning letter, yet the company still plans to resubmit its biologics license application and pursue a 2026 U.S. launch of apitegromab for spinal muscular atrophy, subject to regulatory approval.