secwatch.observer — SEC 8-K summary
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Issuer:     IDEAYA Biosciences, Inc. (IDYA)
CIK:        0001676725
Form:       8-K
Filed at:   2025-09-08T23:59:59+00:00
Accession:  0001193125-25-197605
Event type: other_material
Sentiment:  positive
Materiality: 0.78
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

IDEAYA reports positive Phase 1 data for IDE849 in SCLC, positive Phase 2 darovasertib in UM, positive IDE397 combo data
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- IDE849 (DLL3 ADC) showed 73.2% ORR (52/71) and 47.9% confirmed ORR in SCLC at >=2.4 mg/kg; median PFS 6.7 months.
- Darovasertib neoadjuvant UM trial: 76% (16/21) achieved >=20% tumor shrinkage; 48% had >=20% reduction in simulated radiation dose.
- IDE397 (MAT2A) + Trodelvy in MTAP-del UC: 33% ORR at DL1 (3cPR), 57% ORR at DL2 (3cPR+1uPR); DCR up to 100%.
- Phase 3 OptimUM-10 trial for darovasertib in neoadjuvant primary UM initiated Q2 2025; additional data at ESMO Oct 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1676725/000119312525197605/0001193125-25-197605-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1676725/000119312525197605/d38716d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-197605

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