---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-223230"
form_type: "8-K"
ticker: "IDYA"
cik: "0001676725"
company_name: "IDEAYA Biosciences, Inc."
filed_at: "2024-09-23T23:59:59+00:00"
generated_at: "2026-05-31T02:27:33.912677+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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).

## SEC filing metadata
- accession: 0001193125-24-223230
- form_type: 8-K
- ticker: IDYA
- cik: 0001676725
- company_name: IDEAYA Biosciences, Inc.
- filed_at: 2024-09-23T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1676725/000119312524223230/0001193125-24-223230-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1676725/000119312524223230/d884691d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-223230
- JSON: https://secwatch.observer/filing/0001193125-24-223230.json
- Plain text: https://secwatch.observer/filing/0001193125-24-223230.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.