{"schema_version":"secwatch.filing_event.v1","accession":"0001933414-24-000025","form_type":"8-K","ticker":"MLYS","cik":"0001933414","company_name":"Mineralys Therapeutics, Inc.","filed_at":"2024-06-10T23:59:59+00:00","discovered_at":"2026-05-14T18:03:21.243002+00:00","generated_at":"2026-06-01T05:23:46.592451+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Mineralys revises primary endpoints for two pivotal hypertension trials; topline data expected Q4 2024 and H2 2025","bullets":["FDA agreed to change Launch-HTN primary endpoint to automated office systolic BP at 6 weeks, pooled 50 mg QD; topline data expected H2 2025.","Plan similar revision for Advance-HTN (Phase 2) pending FDA alignment: 24-hour ambulatory systolic BP at 4 weeks, pooled 50 mg QD; topline Q4 2024.","Both trials evaluate lorundrostat for uncontrolled or resistant hypertension; no other design changes or operational impact.","Launch-HTN Phase 3 enrolls up to 1,000 subjects; Advance-HTN Phase 2 had 261 subjects."],"urls":{"canonical":"https://secwatch.observer/filing/0001933414-24-000025","json":"https://secwatch.observer/filing/0001933414-24-000025.json","markdown":"https://secwatch.observer/filing/0001933414-24-000025.md","text":"https://secwatch.observer/filing/0001933414-24-000025.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1933414/000193341424000025/0001933414-24-000025-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1933414/000193341424000025/mlys-20240610.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T05:23:46.592451+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"}