{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-223230","form_type":"8-K","ticker":"IDYA","cik":"0001676725","company_name":"IDEAYA Biosciences, Inc.","filed_at":"2024-09-23T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.072532+00:00","generated_at":"2026-05-31T02:27:33.912677+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"IDEAYA reports positive Phase 2 darovasertib data in neoadjuvant uveal melanoma; FDA supports registrational Phase 3","bullets":["59% of 49 evaluable patients had >=20% ocular tumor shrinkage; 49% had >=30% shrinkage by product of diameters.","Eye preservation rate of 61% in enucleation patients; 11% Grade 3+ AEs, 5% serious AEs, 3% discontinuation rate.","FDA guidance: primary endpoint eye preservation for enucleation, time to vision loss for brachytherapy; ORR potential surrogate.","Phase 3 planned with ~400 patients, two cohorts; 300mg BID dose; broad label possible for low/intermediate/high risk.","Neoadjuvant UM annual incidence ~12,000 in NA/Europe/Australia; IDEAYA owns commercial rights (ex-Novartis license)."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-223230","json":"https://secwatch.observer/filing/0001193125-24-223230.json","markdown":"https://secwatch.observer/filing/0001193125-24-223230.md","text":"https://secwatch.observer/filing/0001193125-24-223230.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1676725/000119312524223230/0001193125-24-223230-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1676725/000119312524223230/d884691d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T02:27:33.912677+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"}