{"schema_version":"secwatch.filing_event.v1","accession":"0001933414-25-000070","form_type":"8-K","ticker":"MLYS","cik":"0001933414","company_name":"Mineralys Therapeutics, Inc.","filed_at":"2025-06-17T23:59:59+00:00","discovered_at":"2026-05-14T18:02:50.499448+00:00","generated_at":"2026-05-19T05:16:48.906971+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Positive Phase 2 Explore-CKD results for lorundrostat; primary endpoint met","bullets":["Lorundrostat 25 mg reduced systolic BP by 9.3 mmHg (–7.5 mmHg placebo-adjusted, p=0.0024) in hypertensive CKD patients.","UACR reduction of 31% (–25.6% placebo-adjusted, p=0.0015) suggests renal protective potential.","Favorable safety profile: 3% SAEs (lorundrostat), 5% hyperkalemia rate; 3% discontinuation due to TEAEs.","Data augment pivotal Phase 3 Launch-HTN and other trials; company plans NDA submission including these results."],"urls":{"canonical":"https://secwatch.observer/filing/0001933414-25-000070","json":"https://secwatch.observer/filing/0001933414-25-000070.json","markdown":"https://secwatch.observer/filing/0001933414-25-000070.md","text":"https://secwatch.observer/filing/0001933414-25-000070.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1933414/000193341425000070/0001933414-25-000070-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1933414/000193341425000070/mlys-20250617.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-19T05:16:48.906971+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"}