secwatch.observer — SEC 8-K summary
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Issuer:     IDEAYA Biosciences, Inc. (IDYA)
CIK:        0001676725
Form:       8-K
Filed at:   2023-11-07T23:59:59+00:00
Accession:  0000950170-23-059717
Event type: earnings
Sentiment:  positive
Materiality: 0.65
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

IDEAYA Q3 cash $511M, darovasertib shows 42% ORR in 1L HLA-A2(-) MUM; registrational trial ongoing
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- Cash, cash equivalents and marketable securities of $511.1M as of Sep 30, 2023; plus $134.7M net proceeds from follow-on and $10M GSK milestone receivable.
- Darovasertib + crizotinib in 1L HLA-A2(-) MUM: ORR 42%, median PFS 7.1 months; Phase 2/3 registrational trial ongoing with >50 sites planned.
- Darovasertib neoadjuvant in primary UM: 50% eye preservation rate (3/6 evaluable), tumor shrinkage in 83% of evaluable patients.
- IDE161 received FDA Fast Track for BRCA1/2 ovarian and breast cancer; Phase 1 expansion initiated in HRD+ tumors.
- IND clearance for GSK101 (Pol Theta) triggered $7M milestone; Werner Helicase DC selected with $3M milestone; IND targeted in 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1676725/000095017023059717/0000950170-23-059717-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1676725/000095017023059717/idya-20231107.htm
  HTML page:      https://secwatch.observer/filing/0000950170-23-059717

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