On Monday, 13 October 2025, Scholar Rock disclosed that the FDA had designated its third‑party manufacturing partner, Catalent Indiana, as Official Action Indicated (OAI). The OAI status signals that the FDA recommends regulatory or administrative actions at the facility, following a routine inspection that raised compliance concerns.
The OAI designation could affect Scholar Rock’s ability to produce apitegromab, its lead spinal muscular atrophy therapy, which relies on the Catalent facility for fill‑finish operations. Scholar Rock has already faced a setback when the FDA rejected its BLA for apitegromab last month, and the company has requested a formal meeting with the FDA to determine next steps for the submission.
Scholar Rock stated it will continue to work with Novo Nordisk, the owner of Catalent Indiana, and will provide additional information during its third‑quarter earnings call scheduled for next month. The OAI designation adds regulatory uncertainty to the company’s commercial launch timeline for apitegromab, and investors will monitor the outcome of the FDA meeting and any corrective actions required at the manufacturing site.
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