secwatch.observer — SEC 8-K summary
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Issuer:     Scholar Rock Holding Corp (SRRK)
CIK:        0001727196
Form:       8-K
Filed at:   2026-03-31T23:59:59+00:00
Accession:  0001104659-26-037350
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Scholar Rock resubmits BLA for apitegromab SMA; PDUFA goal late Sept 2026
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- Resubmission follows Sep 2025 CRL related to Catalent Indiana facility; no other approvability concerns cited.
- FDA acceptance expected within 30 days; review up to 6 months; PDUFA decision target late September 2026.
- Includes second U.S. fill-finish facility after positive Type C meeting on March 3, 2026.
- European MAA for apitegromab progressing; decision anticipated mid-2026.
- CEO David L. Hallal expects U.S. and European approvals and launches this year.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1727196/000110465926037350/0001104659-26-037350-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1727196/000110465926037350/tm2610664d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-037350

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