secwatch.observer — SEC 8-K summary
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Issuer:     Scholar Rock Holding Corp (SRRK)
CIK:        0001727196
Form:       8-K
Filed at:   2026-09-14T12:00:27+00:00
Accession:  0001104659-26-107273
Event type: regulatory
Sentiment:  positive
Materiality: 1.00
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA approves Scholar Rock's ISEMBYLD (apitegromab) for SMA in adults and children ≥2 years
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- FDA approved ISEMBYLD (apitegromab-mstn) for SMA in adults/children ≥2 yrs on SMN2-targeted therapy.
- Phase 3 SAPPHIRE: 2.2-point HFMSE improvement vs placebo (nominal p=0.0121); 34.2% ≥3-point gain vs 13.5% (OR 3.8).
- Safety: fractures 9% ISEMBYLD vs 2% placebo; database >500, some treated >7 years.
- U.S. launch underway, shipping in coming days; awarded Rare Pediatric Disease Priority Review Voucher.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1727196/000110465926107273/0001104659-26-107273-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1727196/000110465926107273/tm2625362d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-107273

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