{"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","discovered_at":"2026-05-14T18:03:09.304653+00:00","generated_at":"2026-05-29T03:00:52.243044+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Edgewise Phase 2 CANYON trial meets primary endpoint; sevasemten reduces CK by 28% in Becker muscular dystrophy","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-129001","json":"https://secwatch.observer/filing/0001104659-24-129001.json","markdown":"https://secwatch.observer/filing/0001104659-24-129001.md","text":"https://secwatch.observer/filing/0001104659-24-129001.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T03:00:52.243044+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}