# Scholar Rock Resubmits Biologics License Application (BLA) to FDA for Apitegromab for Treatment of Children and Adults with Spinal Muscular Atrophy (SMA)
Canonical URL: https://biopharmsignal.com/news/SRRK/scholar-rock-resubmits-biologics-license-application-bla-to-fda-for-apitegromab-for-treatment-of-children-and-adults-with-spinal-muscular-atrophy-sma
Ticker: SRRK
Company: Scholar Rock
Source: Scholar Rock
Published: 2026-03-31 11:00 EST
Original Source URL: https://investors.scholarrock.com
## Summary

Apitegromab BLA resubmission includes Catalent Indiana LLC (part of Novo Nordisk) and second U.S. -based fill-finish facility, aligned with FDA guidance from March 3, 2026 Type C meeting FDA and Novo Nordisk Q1 2026 interactions resulted in Scholar Rock’s alignment with FDA to resubmit apitegromab

## Article Body
Apitegromab BLA resubmission includes Catalent Indiana LLC (part of Novo Nordisk) and second U.S. -based fill-finish facility, aligned with FDA guidance from March 3, 2026 Type C meeting FDA and Novo Nordisk Q1 2026 interactions resulted in Scholar Rock’s alignment with FDA to resubmit apitegromab
## Recent Company News
- 2026-07-20 12:00 EST — [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)](https://biopharmsignal.com/news/SRRK/scholar-rock-provides-update-on-timing-of-committee-for-medicinal-products-for-h-018ed6e6) — Source: Scholar Rock
- 2026-07-17 20:15 EST — [Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)](https://biopharmsignal.com/news/SRRK/scholar-rock-reports-new-employee-inducement-grants-under-nasdaq-listing-rule-56-f0ff2185) — Source: Scholar Rock
- 2026-07-16 12:00 EST — [Scholar Rock to Report Second Quarter 2026 Financial Results on August 6, 2026](https://biopharmsignal.com/news/SRRK/scholar-rock-to-report-second-quarter-2026-financial-results-on-august-6-2026-4387875b) — Source: Scholar Rock
- 2026-06-22 12:00 EST — [Scholar Rock to Showcase Neuromuscular Research Portfolio at 2026 Annual Cure SMA Research and Clinical Care Meeting and 2026 International Research Congress on FSHD](https://biopharmsignal.com/news/SRRK/scholar-rock-to-showcase-neuromuscular-research-portfolio-at-2026-annual-cure-sm-c0fc71a6) — Source: Scholar Rock
- 2026-06-12 20:15 EST — [Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)](https://biopharmsignal.com/news/SRRK/scholar-rock-reports-new-employee-inducement-grants-under-nasdaq-listing-rule-56-77f7a745) — Source: Scholar Rock
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