{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-063028","form_type":"8-K","ticker":"EWTX","cik":"0001710072","company_name":"Edgewise Therapeutics, Inc.","filed_at":"2025-06-26T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.422282+00:00","generated_at":"2026-05-18T18:00:04.303348+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Edgewise announces positive sevasemten data; FDA provides clear path to first Becker therapy","bullets":["MESA OLE: 99% enrollment (85 participants); NSAA scores improved 0.8 pts over 18 months, diverging from natural history declines.","FDA Type C: NSAA endorsed for traditional approval; CANYON alone insufficient; GRAND CANYON may serve as single pivotal study.","GRAND CANYON on track for topline data Q4 2026; highly powered to show NSAA difference vs placebo over 18 months.","Duchenne Phase 2 LYNX/FOX: 10 mg dose selected for Phase 3; well-tolerated; FOX suggests slower decline in post-gene therapy patients.","Plans to meet FDA Q4 2025 for Phase 3 Duchenne design; pivotal study initiation expected in 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-063028","json":"https://secwatch.observer/filing/0001104659-25-063028.json","markdown":"https://secwatch.observer/filing/0001104659-25-063028.md","text":"https://secwatch.observer/filing/0001104659-25-063028.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1710072/000110465925063028/0001104659-25-063028-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1710072/000110465925063028/tm2519221d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T18:00:04.303348+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"}