---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-22-099487"
form_type: "8-K"
ticker: "EWTX"
cik: "0001710072"
company_name: "Edgewise Therapeutics, Inc."
filed_at: "2022-09-13T23:59:59+00:00"
generated_at: "2026-06-23T10:11:43.610132+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Edgewise announces FDA authorization for Phase 2 DMD trial; positive ARCH interim data in BMD

## Summary
- FDA authorized Phase 2 LYNX trial of EDG-5506 in children with DMD; dosing expected Q4 2022.
- ARCH interim data: NSAA improved 1.17 points vs natural history decline of 1.22/year.
- CK reduced 29% and fast skeletal muscle troponin I reduced 74% after 4 months.
- 9 of 12 BMD participants showed improvement or no decline on NSAA; no serious AEs observed.
- EDG-5506 well-tolerated with no discontinuations; all patients dose escalated to 20 mg daily.

## SEC filing metadata
- accession: 0001104659-22-099487
- form_type: 8-K
- ticker: EWTX
- cik: 0001710072
- company_name: Edgewise Therapeutics, Inc.
- filed_at: 2022-09-13T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1710072/000110465922099487/0001104659-22-099487-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1710072/000110465922099487/tm2221772d2_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-22-099487
- JSON: https://secwatch.observer/filing/0001104659-22-099487.json
- Plain text: https://secwatch.observer/filing/0001104659-22-099487.txt

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