---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-107273"
form_type: "8-K"
ticker: "SRRK"
cik: "0001727196"
company_name: "Scholar Rock Holding Corp"
filed_at: "2026-09-14T12:00:27+00:00"
generated_at: "2026-09-14T12:05:32.019320+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 1.0
calibrated_materiality_score: 1.0
confidence: "high"
source: SEC EDGAR
---

# FDA approves Scholar Rock's ISEMBYLD (apitegromab) for SMA in adults and children ≥2 years

## Summary
- 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.

## SEC filing metadata
- accession: 0001104659-26-107273
- form_type: 8-K
- ticker: SRRK
- cik: 0001727196
- company_name: Scholar Rock Holding Corp
- filed_at: 2026-09-14T12:00:27+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 1.0
- calibrated_materiality_score: 1.0
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1727196/000110465926107273/0001104659-26-107273-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1727196/000110465926107273/tm2625362d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-107273
- JSON: https://secwatch.observer/filing/0001104659-26-107273.json
- Plain text: https://secwatch.observer/filing/0001104659-26-107273.txt

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