Scholar Rock Resubmits Biologics License Application for Apitegromab to US FDA

MT Newswires Live03-31

Scholar Rock (SRRK) said Tuesday it has resubmitted to the US Food and Drug Administration the biologics license application for apitegromab as a treatment for children and adults with spinal muscular atrophy.

The company said the resubmitted application followed the FDA's complete response letter in September 2025, which raised issues related to a facility of Catalent Indiana, which is a part of Novo Nordisk (NVO).

Scholar Rock said the FDA has not requested additional corrective actions for the facility and that it has included a second US-based facility in the revised application to support the drug candidate's supply chain.

The company said it expects the target action date in late September.

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