secwatch.observer — SEC 8-K summary
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Issuer:     Edgewise Therapeutics, Inc. (EWTX)
CIK:        0001710072
Form:       8-K
Filed at:   2024-12-16T23:59:59+00:00
Accession:  0001104659-24-129001
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1710072/000110465924129001/0001104659-24-129001-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1710072/000110465924129001/tm2431151d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-129001

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