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Scholar Rock Announces FDA Review of Apitegromab Biologics License Application (BLA) for Spinal Muscular Atrophy (SMA) to Progress with Second Fill-Finish Facility; Approval Decision Anticipated by September 30, 2026 Action Date

Scholar Rock (SRRK)Scholar RockFDA / regulatory

Today, August 7, 2026, Scholar Rock received customer notification from Catalent Indiana LLC (part of Novo Nordisk) that FDA classified the April 2026 site inspection of Catalent Indiana fill-finish facility as Official Action Indicated (OAI) Scholar Rock continuing to collaborate closely with FDA

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Scholar Rock Resubmits Biologics License Application (BLA) to FDA for Apitegromab for Treatment of Children and Adults with Spinal Muscular Atrophy (SMA)

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Scholar Rock Provides Update on Timing of Committee for Medicinal Products for Human Use (CHMP) Opinion for Apitegromab Marketing Authorisation Application (MAA) for Spinal Muscular Atrophy (SMA)

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Scholar Rock

Myostatin Biology Scholar Rock develops therapies that selectively modulate growth factors in their latent forms. Its lead work targets myostatin to improve muscle function while preserving related signaling pathways. Apitegromab Apitegromab is a selective inhibitor of latent myostatin under FDA review for children and adults with spinal...

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Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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52.64 USD
Market cap
5.35B USD
Exchange
NASDAQ
Sector
Biopharma
Location
United States