---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-107721"
form_type: "8-K"
ticker: "SRRK"
cik: "0001727196"
company_name: "Scholar Rock Holding Corp"
filed_at: "2026-09-15T12:30:50+00:00"
generated_at: "2026-09-15T12:35:23.179755+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA approves Scholar Rock's ISEMBYLD for SMA; company clarifies post-marketing safety commitments

## Summary
- FDA approved ISEMBYLD (apitegromab-mstn) for spinal muscular atrophy in adults/children 2+ on SMN2-targeted treatment.
- Corrects prior statement: FDA requires a pregnancy safety study and 15-day fracture alert reports as post-marketing commitments.
- Scholar Rock will conduct the study and submit fracture reports in compliance with FDA's request.

## SEC filing metadata
- accession: 0001104659-26-107721
- form_type: 8-K
- ticker: SRRK
- cik: 0001727196
- company_name: Scholar Rock Holding Corp
- filed_at: 2026-09-15T12:30:50+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1727196/000110465926107721/0001104659-26-107721-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1727196/000110465926107721/tm2625438d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-107721
- JSON: https://secwatch.observer/filing/0001104659-26-107721.json
- Plain text: https://secwatch.observer/filing/0001104659-26-107721.txt

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