{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-243558","form_type":"8-K","ticker":"IDYA","cik":"0001676725","company_name":"IDEAYA Biosciences, Inc.","filed_at":"2025-10-20T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.122373+00:00","generated_at":"2026-05-17T03:15:00.757875+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"IDEAYA reports Phase 2 darovasertib data: median OS 21.1 mo in 1L mUM; 57% eye preservation","bullets":["Darovasertib + crizotinib in 1L mUM: median OS 21.1 mo (historical ~12 mo), median PFS 7.0 mo, ORR 34%, DCR 90%.","Neoadjuvant darovasertib in primary UM: 83% (78/94) of patients achieved tumor shrinkage; 54% >=20% shrinkage.","Among patients recommended for enucleation, 57.1% (24/42) achieved eye preservation; in those with >=20% shrinkage, rate jumped to 95%.","Predicted radiation reduction: 70% of Cohort 2 patients saw any reduction in predicted dose to critical eye structures; 64.9% had reduced 3-year vision loss risk.","FDA Breakthrough Therapy Designation for neoadjuvant darovasertib; registration-enabling Phase 2/3 OptimUM-02 targeting median PFS data by year-end 2025 to Q1 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-243558","json":"https://secwatch.observer/filing/0001193125-25-243558.json","markdown":"https://secwatch.observer/filing/0001193125-25-243558.md","text":"https://secwatch.observer/filing/0001193125-25-243558.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1676725/000119312525243558/0001193125-25-243558-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1676725/000119312525243558/d42028d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T03:15:00.757875+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"}