Update: Scholar Rock Holding Says Apitegromab BLA Review Stays on Track for September 30 PDUFA Date

MT Newswires Live

Aug 10

(Updates with day of announcement in first paragraph, Novo Nordisk's affiliation in the second paragraph, and latest stock moves in the fourth paragraph.)

Scholar Rock Holding (SRRK) said Friday that the FDA review of its apitegromab Biologics License Application for spinal muscular atrophy remains on track for potential approval by the September 30 PDUFA date, with the review now progressing solely with the company's second fill-finish facility.

The company said it received notification on August 7 that the FDA classified an April 2026 inspection of Novo Nordisk's (NVO) Catalent Indiana, one of two fill-finish facilities included in the March 2026 BLA submission, as Official Action Indicated, and it will remove Catalent Indiana from the application.

Scholar Rock said the data package required for FDA review of the second facility was submitted ahead of schedule, with commercial supply already awaiting packaging and labeling at a third-party site.

Shares of Novo Nordisk were down 1.2% in Monday's premarket trading.

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