Scholar Rock falls on FDA review; analysts flag optimistic expectations

Scholar Rock Holding

12/01/2026 15:28

** Shares of drug developer Scholar Rock SRRK.O down 2.5% at $41.12

** SRRK says U.S. FDA has scheduled meeting with third-party manufacturing facility, Catalent Indiana, part of Novo Nordisk NOVOb.CO, in early 2026 to discuss progress of remediation efforts

** Expects resubmission of marketing application of apitegromab for muscle weakness and U.S. launch following FDA's potential approval in 2026

** In September, agency declined to approve apitegromab citing issues at the facility

** "Catalent site could take time to be resolved" - Truist analyst Srikripa Devarakonda

** Adds: "This is in-line with our model baseline assumptions of H1 2026 or mid-2026 submission of BLA and 2027 launch"

** SRRK expects to submit a supplemental application for apitegromab to treat facioscapulohumeral muscular dystrophy with second site later in 2026

** Stock fell 7.3% in 2025

(Reporting by Siddhi Mahatole)

((siddhi.mahatole@thomsonreuters.com))