{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-048160","form_type":"8-K","ticker":"MIST","cik":"0001408443","company_name":"Milestone Pharmaceuticals Inc.","filed_at":"2025-05-14T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.190771+00:00","generated_at":"2026-05-21T08:15:15.850818+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Milestone Pharma Q1 net loss $20.8M; CRL issues unresolved; Type A meeting requested","bullets":["Q1 net loss $20.8M vs $10.4M YoY; no revenue; cash $56.0M down from $69.7M.","FDA CRL for CARDAMYST (etripamil) in PSVT cites nitrosamine impurities and facility GMP issues.","Type A meeting requested with FDA to address CMC concerns; no clinical safety/efficacy issues.","New USPTO method-of-use patent extends etripamil IP protection to July 2042.","Phase 3 AFib-RVR enrollment paused to prioritize CRL resolution; commercial ramp temporarily halted."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-048160","json":"https://secwatch.observer/filing/0001104659-25-048160.json","markdown":"https://secwatch.observer/filing/0001104659-25-048160.md","text":"https://secwatch.observer/filing/0001104659-25-048160.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1408443/000110465925048160/0001104659-25-048160-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1408443/000110465925048160/tm2515019d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-21T08:15:15.850818+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"}