---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-129001"
form_type: "8-K"
ticker: "EWTX"
cik: "0001710072"
company_name: "Edgewise Therapeutics, Inc."
filed_at: "2024-12-16T23:59:59+00:00"
generated_at: "2026-05-29T03:00:52.243044+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Edgewise Phase 2 CANYON trial meets primary endpoint; sevasemten reduces CK by 28% in Becker muscular dystrophy

## Summary
- Primary endpoint met: CK decreased 28% vs placebo over months 6-12 in adults (p=0.02).
- Key secondary NSAA showed 1.1-point trend favoring sevasemten (p=0.16); treatment group had more advanced disease at baseline.
- TNNI2 biomarker reduced 77% vs placebo (p<0.001); functional tests (10-m walk, stair climb, 100-m) trended positive.
- Sevasemten well-tolerated; no new safety concerns in adults or adolescents.
- GRAND CANYON pivotal cohort enrollment on track for Q1 2025; 99% of eligible patients entered open-label extension.

## SEC filing metadata
- accession: 0001104659-24-129001
- form_type: 8-K
- ticker: EWTX
- cik: 0001710072
- company_name: Edgewise Therapeutics, Inc.
- filed_at: 2024-12-16T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1710072/000110465924129001/0001104659-24-129001-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1710072/000110465924129001/tm2431151d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-129001
- JSON: https://secwatch.observer/filing/0001104659-24-129001.json
- Plain text: https://secwatch.observer/filing/0001104659-24-129001.txt

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