secwatch.observer — SEC 8-K summary
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Issuer:     Scholar Rock Holding Corp (SRRK)
CIK:        0001727196
Form:       8-K
Filed at:   2025-09-23T23:59:59+00:00
Accession:  0001104659-25-092317
Event type: regulatory
Sentiment:  negative
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1727196/000110465925092317/0001104659-25-092317-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1727196/000110465925092317/tm2526733d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-092317

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