{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-001099","form_type":"8-K","ticker":"MIST","cik":"0001408443","company_name":"Milestone Pharmaceuticals Inc.","filed_at":"2026-01-06T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.008068+00:00","generated_at":"2026-05-16T11:30:50.154424+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Milestone Pharma announces EMA acceptance of MAA for etripamil in PSVT; decision expected Q1 2027","bullets":["EMA accepted Marketing Authorization Application for etripamil nasal spray (TACHYMIST) for PSVT; decision expected Q1 2027.","Phase 3 RAPID trial: 64% conversion to sinus rhythm at 30 min vs 31% placebo (p<0.001); median time 17 min vs 54 min.","Drug is conditionally approved brand name TACHYMIST in Europe; ~2 million PSVT patients in Europe.","MAA includes global clinical data that supported U.S. FDA approval of etripamil for PSVT."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-001099","json":"https://secwatch.observer/filing/0001104659-26-001099.json","markdown":"https://secwatch.observer/filing/0001104659-26-001099.md","text":"https://secwatch.observer/filing/0001104659-26-001099.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1408443/000110465926001099/0001104659-26-001099-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1408443/000110465926001099/tm261989d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T11:30:50.154424+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"}