Scholar Rock falls on FDA review; analysts flag optimistic expectations
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
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