{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-076468","form_type":"8-K","ticker":"MIST","cik":"0001408443","company_name":"Milestone Pharmaceuticals Inc.","filed_at":"2025-08-12T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.910732+00:00","generated_at":"2026-05-17T14:24:45.491646+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Milestone Pharma: FDA accepts CRL response for CARDAMYST; new Dec 13 PDUFA date; Q2 net loss $13M","bullets":["FDA accepted CRL response for CARDAMYST (etripamil) for PSVT; new PDUFA target Dec 13, 2025.","Completed public equity offering in July, raising up to $170M gross if warrants exercised; net proceeds ~$48.7M.","Amended royalty agreement with RTW, extending approval deadline to Dec 31, 2025 for up to $75M payment.","Cash, cash equivalents and short-term investments $43.4M as of June 30; net loss $13M for Q2 vs $9.4M Q2 2024.","Commercial expense increased to $5.1M in Q2 (vs $1.8M) as company maintains launch capability pending approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-076468","json":"https://secwatch.observer/filing/0001104659-25-076468.json","markdown":"https://secwatch.observer/filing/0001104659-25-076468.md","text":"https://secwatch.observer/filing/0001104659-25-076468.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1408443/000110465925076468/0001104659-25-076468-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1408443/000110465925076468/tm2523169d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T14:24:45.491646+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"}