secwatch.observer — SEC 8-K summary
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Issuer:     IDEAYA Biosciences, Inc. (IDYA)
CIK:        0001676725
Form:       8-K
Filed at:   2024-09-23T23:59:59+00:00
Accession:  0001193125-24-223230
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

IDEAYA reports positive Phase 2 darovasertib data in neoadjuvant uveal melanoma; FDA supports registrational Phase 3
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- 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).

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1676725/000119312524223230/0001193125-24-223230-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1676725/000119312524223230/d884691d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-223230

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