{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-25-011459","form_type":"8-K","ticker":"MLYS","cik":"0001933414","company_name":"Mineralys Therapeutics, Inc.","filed_at":"2025-03-10T23:59:59+00:00","discovered_at":"2026-05-14T18:03:05.596914+00:00","generated_at":"2026-05-25T02:11:56.407111+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Lorundrostat meets primary endpoints in Launch-HTN Phase 3 & Advance-HTN Phase 2 with significant BP reduction","bullets":["Launch-HTN Phase 3: 50 mg lorundrostat achieved 9.1 mmHg placebo-adjusted SBP reduction (p<0.0001) at week 6 and 11.7 mmHg at week 12.","Advance-HTN Phase 2: 50 mg achieved 7.9 mmHg placebo-adjusted SBP reduction by 24hr ABPM at week 12 (p<0.0001).","Safety profile favorable: SAEs 2.2% (50 mg) vs 3.0% placebo; hyperkalemia (>6.0 mmol/L) 1.1% in Launch-HTN, 5.3% in Advance-HTN.","Diverse enrollment: Launch-HTN 47% women, 29% Black/African American; Advance-HTN 40% women, 50% Black/African American.","Full Advance-HTN results to be presented at ACC Scientific Sessions on March 29, 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-25-011459","json":"https://secwatch.observer/filing/0001628280-25-011459.json","markdown":"https://secwatch.observer/filing/0001628280-25-011459.md","text":"https://secwatch.observer/filing/0001628280-25-011459.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1933414/000162828025011459/0001628280-25-011459-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1933414/000162828025011459/mlys-20250310.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-25T02:11:56.407111+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"}