{"schema_version":"secwatch.filing_event.v1","accession":"0001933414-23-000028","form_type":"8-K","ticker":"MLYS","cik":"0001933414","company_name":"Mineralys Therapeutics, Inc.","filed_at":"2023-05-02T23:59:59+00:00","discovered_at":"2026-05-14T18:03:41.596369+00:00","generated_at":"2026-06-16T03:52:55.414139+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Mineralys first patient dosed in ADVANCE-HTN pivotal trial of lorundrostat for hypertension","bullets":["ADVANCE-HTN trial to enroll up to 300 adults with uncontrolled or resistant hypertension.","Primary endpoint: change in systolic BP vs placebo after 12 weeks (24-hr ambulatory monitoring).","Topline data from ADVANCE-HTN expected in first half of 2024.","Second pivotal Phase 3 trial to begin enrolling H2 2023, data anticipated mid-2025.","Phase 2 CKD trial for lorundrostat expected to start mid-2023, topline data H1 2024."],"urls":{"canonical":"https://secwatch.observer/filing/0001933414-23-000028","json":"https://secwatch.observer/filing/0001933414-23-000028.json","markdown":"https://secwatch.observer/filing/0001933414-23-000028.md","text":"https://secwatch.observer/filing/0001933414-23-000028.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1933414/000193341423000028/0001933414-23-000028-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1933414/000193341423000028/mlys202305028k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-16T03:52:55.414139+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"}