---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-092317"
form_type: "8-K"
ticker: "SRRK"
cik: "0001727196"
company_name: "Scholar Rock Holding Corp"
filed_at: "2025-09-23T23:59:59+00:00"
generated_at: "2026-05-17T05:53:17.906483+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA issues CRL for Scholar Rock's apitegromab BLA due to Catalent fill-finish observations

## Summary
- CRL cites observations at Catalent Indiana fill-finish facility; no efficacy/safety issues.
- Scholar Rock intends to resubmit BLA upon resolution of Catalent remediation.
- Catalent submitted comprehensive response in August 2025; FDA kept apprised of progress.
- EU MAA under review; decision expected mid-2026; launch anticipated H2 2026 in Germany first.

## SEC filing metadata
- accession: 0001104659-25-092317
- form_type: 8-K
- ticker: SRRK
- cik: 0001727196
- company_name: Scholar Rock Holding Corp
- filed_at: 2025-09-23T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1727196/000110465925092317/0001104659-25-092317-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1727196/000110465925092317/tm2526733d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-092317
- JSON: https://secwatch.observer/filing/0001104659-25-092317.json
- Plain text: https://secwatch.observer/filing/0001104659-25-092317.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.