secwatch.observer — SEC 8-K summary
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Issuer:     Scholar Rock Holding Corp (SRRK)
CIK:        0001727196
Form:       8-K
Filed at:   2025-12-02T23:59:59+00:00
Accession:  0001104659-25-117522
Event type: regulatory
Sentiment:  negative
Materiality: 0.70
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1727196/000110465925117522/0001104659-25-117522-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1727196/000110465925117522/tm2532170d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-117522

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer