Scholar Rock drops Catalent Indiana from apitegromab BLA after FDA flags site inspection as OAI

Reuters2026/08/07 20:21

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Scholar Rock’s FDA review of the apitegromab BLA for spinal muscular atrophy will proceed with only its second fill-finish facility.
Catalent Indiana was dropped after the FDA classified its April 2026 inspection as Official Action Indicated.
The PDUFA action date remains September 30, 2026, with commercialization supply from the second facility awaiting packaging and labeling.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Scholar Rock Holding Corporation published the original content used to generate this news brief via Business Wire (Ref. ID: 20260807011647) on August 07, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Scholar Rock drops Catalent Indiana from apitegromab BLA after FDA flags site inspection as OAI

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