secwatch.observer — SEC 8-K summary
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Issuer:     IDEAYA Biosciences, Inc. (IDYA)
CIK:        0001676725
Form:       8-K
Filed at:   2025-10-20T23:59:59+00:00
Accession:  0001193125-25-243558
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

IDEAYA reports Phase 2 darovasertib data: median OS 21.1 mo in 1L mUM; 57% eye preservation
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1676725/000119312525243558/0001193125-25-243558-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1676725/000119312525243558/d42028d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-243558

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer