{"schema_version":"secwatch.filing_event.v1","accession":"0001933414-26-000048","form_type":"8-K","ticker":"MLYS","cik":"0001933414","company_name":"Mineralys Therapeutics, Inc.","filed_at":"2026-03-09T23:59:59+00:00","discovered_at":"2026-05-14T18:02:36.812093+00:00","generated_at":"2026-05-15T18:12:51.129980+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"FDA accepts Mineralys' NDA for hypertension drug lorundrostat; PDUFA Dec 22, 2026","bullets":["FDA accepted NDA for lorundrostat for hypertension in combination with other antihypertensives; PDUFA target date December 22, 2026.","Phase 2 Explore-OSA trial did not meet primary endpoint; lorundrostat did not reduce apnea-hypopnea index vs placebo.","Lorundrostat showed 11.1 mmHg BP reduction vs 1.0 mmHg for placebo (p<0.0001) at week 4; placebo-adjusted reduction 6.2 mmHg (p<0.0003).","Safety favorable: no serum potassium >5.5 mmol/L; analysis ongoing for other endpoints.","Company believes lorundrostat has potential for resistant/uncontrolled hypertension; topline data from Explore-OSA reported."],"urls":{"canonical":"https://secwatch.observer/filing/0001933414-26-000048","json":"https://secwatch.observer/filing/0001933414-26-000048.json","markdown":"https://secwatch.observer/filing/0001933414-26-000048.md","text":"https://secwatch.observer/filing/0001933414-26-000048.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1933414/000193341426000048/0001933414-26-000048-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1933414/000193341426000048/mlys-20260306.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T18:12:51.129980+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"}