{"schema_version":"secwatch.filing_event.v1","accession":"0001933414-26-000054","form_type":"8-K","ticker":"MLYS","cik":"0001933414","company_name":"Mineralys Therapeutics, Inc.","filed_at":"2026-03-12T23:59:59+00:00","discovered_at":"2026-05-14T18:02:36.812397+00:00","generated_at":"2026-05-15T13:55:23.801398+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Mineralys Therapeutics reports Q4/FY2025 results; FDA accepts lorundrostat NDA, PDUFA Dec 22, 2026","bullets":["FDA accepted NDA for lorundrostat for hypertension; PDUFA target date December 22, 2026.","Cash, cash equivalents and investments totaled $656.6M at Dec 31, 2025, expected to fund operations into 2028.","Net loss for FY2025 was $154.7M vs $177.8M in FY2024; Q4 net loss $32.2M vs $48.9M.","Explore-OSA Phase 2 trial did not meet primary AHI endpoint at 4 weeks; showed clinically meaningful BP reduction.","R&D expenses fell to $132.0M in FY2025 from $168.6M in FY2024, driven by conclusion of pivotal program."],"urls":{"canonical":"https://secwatch.observer/filing/0001933414-26-000054","json":"https://secwatch.observer/filing/0001933414-26-000054.json","markdown":"https://secwatch.observer/filing/0001933414-26-000054.md","text":"https://secwatch.observer/filing/0001933414-26-000054.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1933414/000193341426000054/0001933414-26-000054-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1933414/000193341426000054/mlys-20260312.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T13:55:23.801398+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"}