secwatch.observer — SEC 8-K summary
======================================

Issuer:     IDEAYA Biosciences, Inc. (IDYA)
CIK:        0001676725
Form:       8-K
Filed at:   2026-04-13T23:59:59+00:00
Accession:  0001193125-26-151893
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

IDEAYA announces Phase 2/3 trial met primary endpoint; darovasertib combo reduces progression risk by 58%
--------------------------------------------------------------------------------

- Darovasertib + crizotinib reduced risk of disease progression by 58% (HR 0.42, p<0.0001) in 1L HLA-A*02:01-negative mUM.
- Median PFS 6.9 months vs 3.1 months for investigator choice therapy (ICT) arm.
- ORR 37.1% vs 5.8% for ICT; 5 complete responses in combo arm, none in ICT.
- NDA submission to FDA targeted for second half of 2026.
- Safety profile manageable; Grade 3+ events included diarrhea, syncope, hypotension.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1676725/000119312526151893/0001193125-26-151893-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1676725/000119312526151893/d114952d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-151893

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