{"schema_version":"secwatch.filing_event.v1","accession":"0001933414-26-000002","form_type":"8-K","ticker":"MLYS","cik":"0001933414","company_name":"Mineralys Therapeutics, Inc.","filed_at":"2026-01-06T23:59:59+00:00","discovered_at":"2026-05-14T18:02:36.811777+00:00","generated_at":"2026-05-16T11:34:09.731860+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Mineralys files NDA for lorundrostat, expects Explore-OSA data Q1 2026","bullets":["Filed new drug application for lorundrostat with FDA in late 2025.","Topline results from Phase 2 Explore-OSA trial in hypertension & moderate-severe OSA expected Q1 2026.","Phase 2 Explore-CKD met primary endpoint on systolic BP reduction and showed meaningful proteinuria reduction.","Phase 3 Launch-HTN and Advance-HTN trials both met primary endpoints in uncontrolled/resistant hypertension.","Management to participate in LifeSci Partners Corporate Access event Jan 12-14, 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001933414-26-000002","json":"https://secwatch.observer/filing/0001933414-26-000002.json","markdown":"https://secwatch.observer/filing/0001933414-26-000002.md","text":"https://secwatch.observer/filing/0001933414-26-000002.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1933414/000193341426000002/0001933414-26-000002-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1933414/000193341426000002/mlys-20260106.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T11:34:09.731860+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"}