---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-117522"
form_type: "8-K"
ticker: "SRRK"
cik: "0001727196"
company_name: "Scholar Rock Holding Corp"
filed_at: "2025-12-02T23:59:59+00:00"
generated_at: "2026-05-16T15:45:24.865313+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Scholar Rock manufacturing partner Catalent Indiana receives FDA Warning Letter; 2026 apitegromab launch still expected

## Summary
- Catalent Indiana (Novo Nordisk) received FDA Warning Letter for facility with 'official action indicated' classification.
- Scholar Rock reiterates expectation to resubmit BLA for apitegromab in SMA and achieve U.S. launch in 2026.
- Company continues to collaborate with Catalent to resolve FDA issues; no change to prior timeline.

## SEC filing metadata
- accession: 0001104659-25-117522
- form_type: 8-K
- ticker: SRRK
- cik: 0001727196
- company_name: Scholar Rock Holding Corp
- filed_at: 2025-12-02T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1727196/000110465925117522/0001104659-25-117522-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1727196/000110465925117522/tm2532170d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-117522
- JSON: https://secwatch.observer/filing/0001104659-25-117522.json
- Plain text: https://secwatch.observer/filing/0001104659-25-117522.txt

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