{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-065806","form_type":"8-K","ticker":"MIST","cik":"0001408443","company_name":"Milestone Pharmaceuticals Inc.","filed_at":"2024-05-29T23:59:59+00:00","discovered_at":"2026-05-14T18:03:18.285801+00:00","generated_at":"2026-06-01T07:38:23.772654+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 gets FDA NDA acceptance for CARDAMYST (etripamil) nasal spray for PSVT","bullets":["FDA accepted NDA on May 26, 2024 for CARDAMYST (etripamil) nasal spray for paroxysmal supraventricular tachycardia (PSVT).","PDUFA target date set at 10 months from acceptance (approx. March 2025).","CEO Joseph Oliveto cites progress toward a new self-administered treatment option for PSVT patients.","CARDAMYST clinical program represents the largest data package ever studied for acute self-management of PSVT.","Brand name CARDAMYST is conditionally approved by FDA; commercial preparations continue for potential launch."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-065806","json":"https://secwatch.observer/filing/0001104659-24-065806.json","markdown":"https://secwatch.observer/filing/0001104659-24-065806.md","text":"https://secwatch.observer/filing/0001104659-24-065806.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1408443/000110465924065806/0001104659-24-065806-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1408443/000110465924065806/tm2415708d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T07:38:23.772654+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"}