# SRRK PDUFA Calendar: FDA Decision Dates & Catalyst Timeline

Canonical URL: https://biopharmsignal.com/pdufa-calendar/SRRK
Company: Scholar Rock

BioPharmSignal tracks active PDUFA and FDA decision milestones associated with SRRK.

## SRRK PDUFA Milestones

- 2025-09-23 — CRL — FDA issued Complete Response Letter. The sponsor reported that FDA issued a Complete Response Letter for Apitegromab on September 23, 2025. This list-only hi...
  Company: Scholar Rock
  Source: https://www.sec.gov/Archives/edgar/data/1727196/000110465925092317/tm2526733d1_ex99-1.htm
  Event detail: https://biopharmsignal.com/pdufa-calendar/SRRK/apitegromab-apitegromab-bla.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2025/september (September 2025)
- 2026-09-30 — PDUFA — FDA decision expected. FDA assigned a September 30, 2026 PDUFA action date to the accepted apitegromab BLA resubmission.
  Company: Scholar Rock
  Source: https://investors.scholarrock.com/news-releases/news-release-details/scholar-rock-reports-first-quarter-2026-financial-results-and/
  Event detail: https://biopharmsignal.com/pdufa-calendar/SRRK/apitegromab-spinal-muscular-atrophy-review-2.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2026/september (September 2026)

## Related Pages

- Company page: https://biopharmsignal.com/company/SRRK
- Interactive PDUFA Calendar: https://biopharmsignal.com/pdufa-calendar

## FAQ

### What does the SRRK PDUFA calendar show?

It shows active PDUFA and FDA decision milestones associated with SRRK, including decision dates, application stage, and summary details when available.
### Where can I find more context for SRRK?

Use the BioPharmSignal company page for SRRK to read related news, stock data, sector context, and company-specific updates.
### Are these dates investment advice?

No. PDUFA dates are research inputs, not investment recommendations. Always review primary sources and understand the clinical and regulatory context.