---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-098894"
form_type: "8-K"
ticker: "SRRK"
cik: "0001727196"
company_name: "Scholar Rock Holding Corp"
filed_at: "2025-10-14T23:59:59+00:00"
generated_at: "2026-05-17T03:55:29.376696+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "medium"
source: SEC EDGAR
---

# Scholar Rock notified that FDA classifies Catalent Indiana facility as 'official action indicated'

## Summary
- Novo Nordisk informed Scholar Rock on Oct 10 that FDA classified Catalent Indiana (owned by Novo Nordisk) as 'official action indicated' (OAI).
- OAI classification follows a Form FDA 483 issued July 14, 2025, citing significant objectionable conditions at the facility.
- Filing does not specify the impact on Scholar Rock's manufacturing, supply chain, or regulatory timelines.
- Scholar Rock provided no assessment of potential delays or financial effect in the filing.

## SEC filing metadata
- accession: 0001104659-25-098894
- form_type: 8-K
- ticker: SRRK
- cik: 0001727196
- company_name: Scholar Rock Holding Corp
- filed_at: 2025-10-14T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: medium
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1727196/000110465925098894/0001104659-25-098894-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1727196/000110465925098894/tm2528675d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-098894
- JSON: https://secwatch.observer/filing/0001104659-25-098894.json
- Plain text: https://secwatch.observer/filing/0001104659-25-098894.txt

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