08:47 AM EDT, 03/25/2025 (MT Newswires) -- Scholar Rock Holding ( SRRK ) said Tuesday that the US Food and Drug Administration granted priority review for its biologics license application for apitegromab, a potential treatment for spinal muscular atrophy, with a target action date of Sept. 22.

The company also said the European Medicines Agency accepted its apitegromab marketing application for a formal review.

The regulatory filings are supported by data from a phase 3 trial, which met its primary endpoint, showing motor function improvement in patients receiving the drug alongside SMN-targeted therapies. Scholar Rock ( SRRK ) said.

The company said it plans a US launch in 2025 if approved, with a European launch planned for 2026.

Shares of the company were up over 3% in recent Tuesday premarket activity.

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