Search...
Scholar Rock Updates on FDA Warning and Apitegromab Launch Plans
I'm PortAI, I can summarize articles.
Scholar Rock Holding Corp provided updates on FDA interactions and product launch plans. FDA issued a warning letter to Catalent Indiana on facility issues, which are being resolved. Scholar Rock plans to resubmit its biologics license application in 2026. U.S. launch of apitegromab for spinal muscular atrophy expected post-approval.
On December 2, 2025, Scholar Rock Holding Corp provided updates on FDA interactions and product launch plans.
Key Highlights:
- FDA issued a warning letter to Catalent Indiana on facility issues.
- Catalent Indiana is working with the FDA to resolve these issues.
- Scholar Rock plans to resubmit its biologics license application in 2026.
- U.S. launch of apitegromab for spinal muscular atrophy expected post-approval.
Original SEC Filing: Scholar Rock Holding Corp [ SRRK ] - 8-K - Dec. 02, 2025
This is an AI-powered summary. It may contain inaccuracies. Consider verifying important information with the source. Please note this summary is solely based on documents filed with the SEC.
Source: TradingView The copyright of this article belongs to the original author/organization.
The views expressed herein are solely those of the author and do not reflect the stance of the platform. The content is intended for investment reference purposes only and shall not be considered as investment advice. Please contact us if you have any questions or suggestions regarding the content services provided by the platform.
Post your comment
No Comments