{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-120904","form_type":"8-K","ticker":"MIST","cik":"0001408443","company_name":"Milestone Pharmaceuticals Inc.","filed_at":"2025-12-15T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.329647+00:00","generated_at":"2026-05-16T13:11:33.808689+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Milestone receives FDA approval for CARDAMYST (etripamil) nasal spray for PSVT","bullets":["FDA approved CARDAMYST (etripamil) on Dec 12, 2025 for self-administration in adults with PSVT; first new treatment in 30+ years.","Phase 3 RAPID: 64% converted to sinus rhythm within 30 min vs 31% placebo (HR=2.62, p<0.001); median time 17 min vs 54 min.","Product expected in retail pharmacies Q1 2026; company well-capitalized for launch with existing capital and royalty financing.","FDA approval enables AFib-RVR development under sNDA pathway; Phase 3 program planned."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-120904","json":"https://secwatch.observer/filing/0001104659-25-120904.json","markdown":"https://secwatch.observer/filing/0001104659-25-120904.md","text":"https://secwatch.observer/filing/0001104659-25-120904.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1408443/000110465925120904/0001104659-25-120904-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1408443/000110465925120904/tm2533390d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T13:11:33.808689+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"}