{"schema_version":"secwatch.filing_event.v1","accession":"0001933414-25-000002","form_type":"8-K","ticker":"MLYS","cik":"0001933414","company_name":"Mineralys Therapeutics, Inc.","filed_at":"2025-01-08T23:59:59+00:00","discovered_at":"2026-05-14T18:03:05.596301+00:00","generated_at":"2026-05-28T07:14:50.703126+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"FDA clears IND for Mineralys' lorundrostat Phase 2 trial in obstructive sleep apnea with hypertension","bullets":["FDA cleared IND for Phase 2 trial of lorundrostat in moderate-to-severe OSA with hypertension.","Trial to evaluate effect on apnea-hypopnea frequency & nocturnal hypertension; initiation expected Q1 2025.","Approximately 40 subjects, placebo-controlled crossover design at up to 40 sites.","Cash, cash equivalents & investments expected to fund operations through Q1 2026.","This is the third targeted indication for lorundrostat, following hypertension and CKD."],"urls":{"canonical":"https://secwatch.observer/filing/0001933414-25-000002","json":"https://secwatch.observer/filing/0001933414-25-000002.json","markdown":"https://secwatch.observer/filing/0001933414-25-000002.md","text":"https://secwatch.observer/filing/0001933414-25-000002.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1933414/000193341425000002/0001933414-25-000002-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1933414/000193341425000002/mlys-20250108.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-28T07:14:50.703126+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"}