secwatch.observer — SEC 8-K summary
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Issuer:     IDEAYA Biosciences, Inc. (IDYA)
CIK:        0001676725
Form:       8-K
Filed at:   2026-06-01T20:05:32+00:00
Accession:  0001193125-26-251399
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

IDEAYA's darovasertib combo meets primary endpoint in Phase 2/3 OptimUM-02 trial for metastatic uveal melanoma
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- Darovasertib + crizotinib achieved median PFS 6.9 months vs 3.1 months for investigator's choice (HR=0.42, p<0.0001) by BICR, reducing risk of progression by 58%.
- Objective response rate 37.1% (combo) vs 5.8% (control) by BICR; disease control rate 73.3% vs 31.1%.
- Grade 3/4 TRAEs 40.6% vs 37.0%; treatment-related discontinuations low (darovasertib 2.5%, crizotinib 10.0% vs ICT 19.0%).
- FDA agreed to review darovasertib NDA under Real-Time Oncology Review; submission expected in H2 2026.
- Overall survival data immature but early trend favoring combo; future analysis will support full approval.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1676725/000119312526251399/0001193125-26-251399-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1676725/000119312526251399/d138848d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-251399

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