{"schema_version":"secwatch.filing_event.v1","accession":"0001933414-23-000048","form_type":"8-K","ticker":"MLYS","cik":"0001933414","company_name":"Mineralys Therapeutics, Inc.","filed_at":"2023-07-17T23:59:59+00:00","discovered_at":"2026-05-14T18:03:36.086227+00:00","generated_at":"2026-06-13T07:56:30.099366+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Mineralys expands lorundrostat Phase 2 trial to include SGLT2i combo for CKD, start H2 2023","bullets":["Two-part Phase 2 trial: Part A (proof-of-concept) up to 100 subjects with mild-moderate CKD; Part B (safety) up to 20 subjects with moderate-severe CKD.","Part A tests lorundrostat 50mg alone and in combination with dapagliflozin 10mg vs placebo over 12+12 weeks.","Part B is open-label dose escalation (25mg to 50mg) in renally compromised patients (eGFR 25-44).","Topline data expected between Q4 2024 and Q1 2025.","Program builds on aldosterone's role in CKD progression and positive Target-HTN trial results."],"urls":{"canonical":"https://secwatch.observer/filing/0001933414-23-000048","json":"https://secwatch.observer/filing/0001933414-23-000048.json","markdown":"https://secwatch.observer/filing/0001933414-23-000048.md","text":"https://secwatch.observer/filing/0001933414-23-000048.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1933414/000193341423000048/0001933414-23-000048-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1933414/000193341423000048/mlys-20230717.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T07:56:30.099366+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"}