{"schema_version":"secwatch.filing_event.v1","accession":"0001933414-23-000096","form_type":"8-K","ticker":"MLYS","cik":"0001933414","company_name":"Mineralys Therapeutics, Inc.","filed_at":"2023-12-22T23:59:59+00:00","discovered_at":"2026-05-14T18:03:31.419829+00:00","generated_at":"2026-06-07T08:23:20.914719+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Mineralys doses first subject in Phase 3 Launch-HTN trial; topline data expected 2H 2025","bullets":["First subject dosed in Launch-HTN (NCT06153693), a global Phase 3 trial enrolling up to ~1,000 patients.","Trial evaluates lorundrostat as add-on for uncontrolled or resistant hypertension on 2-5 background drugs.","Three arms: placebo, lorundrostat 50 mg QD, or 50 mg titrated to 100 mg QD at week 6.","Primary endpoint: change in systolic BP vs placebo at 12 weeks by automated office measurement.","Topline data from Advance-HTN (first pivotal trial) expected in 2H 2024; Transform-HTN OLE ongoing."],"urls":{"canonical":"https://secwatch.observer/filing/0001933414-23-000096","json":"https://secwatch.observer/filing/0001933414-23-000096.json","markdown":"https://secwatch.observer/filing/0001933414-23-000096.md","text":"https://secwatch.observer/filing/0001933414-23-000096.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1933414/000193341423000096/0001933414-23-000096-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1933414/000193341423000096/mlys-20231221.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T08:23:20.914719+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"}