IDEAYA Biosciences Completes Targeted Full Enrollment in Randomized Pivotal Phase 2/3 Trial (OptimUM-02) of Darovasertib in Combination with Crizotinib in First-line HLA*A2-Negative Metastatic Uveal Melanoma

Targeted enrollment of 435 patients to enable potential full approval filing has been completed in OptimUM-02 trial Topline data, including median PFS, are expected in 1Q 2026 to support a potential accelerated approval filing in the United States SOUTH SAN FRANCISCO, Calif. , Dec. 11, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, today announced it has completed its targeted full enrollment of 435 patients in the registration-enabling Phase 2/3 trial (OptimUM-02) evaluating darovasertib, the company's investigational oral protein kinase C (PKC) inhibitor, in combination with Pfizer's crizotinib, an oral c-MET inhibitor, in first line (1L) HLA*A2-negative metastatic uveal melanoma (mUM).

PRNewsWire • Dec 11, 2025

IDEAYA Biosciences Announces IND Submission for IDE574, a Potential First-In-Class KAT6/7 Dual Inhibitor for Breast and Lung Cancers

Phase 1 dose escalation trial of monotherapy IDE574 expected to begin in 1Q 2026 Targeting to present preclinical data detailing pharmacologic profile and evidence of anti-tumor activity in solid tumor models at a medical conference in 1H 2026 SOUTH SAN FRANCISCO, Calif. , Dec. 10, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, announced the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for IDE574, a potential first-in-class KAT6/7 dual inhibitor with high selectivity over related KAT5/8 enzymes.

PRNewsWire • Dec 10, 2025

IDE034, a Bispecific ADC Licensed by Biocytogen to IDEAYA, Receives FDA IND Clearance

BEIJING--(BUSINESS WIRE)--Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), announced that its partner IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision oncology company, has received the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial of IDE034, a potential first-in-class B7H3/PTK7 bispecific antibody-drug conjugate (ADC). IDEAYA expects to begin patient enrollm.

Business Wire • Dec 5, 2025

IDEAYA Biosciences, Inc. (IDYA) Presents at Citi Annual Global Healthcare Conference 2025 Transcript

IDEAYA Biosciences, Inc. (IDYA) Presents at Citi Annual Global Healthcare Conference 2025 Transcript

Seeking Alpha • Dec 2, 2025

IDEAYA Biosciences Announces IND Clearance for IDE034, a Potential First-in-Class Bispecific B7H3/PTK7 TOP1 ADC Targeting Multiple Solid Tumor Types

B7H3 and PTK7 is co-expressed in multiple solid tumor types, including lung, colorectal, and head and neck cancers, at approximately 30%, 46%, and 27%, respectively Deep and durable regressions observed with IDE034 monotherapy in multiple preclinical in-vivo models with B7H3 and PTK7 co-expression Enhanced durability with IDE034 and IDE161 PARG inhibitor combination in preclinical in vivo models; targeting to share additional preclinical data supporting mechanistic rationale at a medical conference in H1 2026 SOUTH SAN FRANCISCO, Calif. and SHANGHAI, Dec. 1, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial to evaluate IDE034, a potential first-in-class bispecific B7H3/PTK7 TOP1 antibody-drug conjugate (ADC).

PRNewsWire • Dec 1, 2025

IDEAYA Biosciences Announces Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

SOUTH SAN FRANCISCO, Calif. , Nov. 28, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that, on November 26, 2025, the Compensation Committee of IDEAYA's Board of Directors granted non-qualified stock options to purchase an aggregate of 17,600 shares of the Company's common stock to a newly hired employee.

PRNewsWire • Nov 28, 2025

Ideaya Biosciences: Primed For Success - Major Eye Cancer Catalyst Weeks Away

Ideaya Biosciences, Inc. is a precision oncology company with a robust pipeline, highlighted by lead asset darovasertib for uveal melanoma. IDYA's darovasertib shows promising Phase 2 results and multiple pivotal studies, with a potential $500M+ peak revenue opportunity and a strong partnership with Servier. The pipeline includes collaborations with major pharma and several near-term catalysts, suggesting IDYA's current $3.1B valuation undervalues its broader portfolio.

Seeking Alpha • Nov 25, 2025

IDEAYA Biosciences to Participate in Upcoming December 2025 Investor Relations Events

SOUTH SAN FRANCISCO, Calif. , Nov. 24, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation in the upcoming investor relations events.

PRNewsWire • Nov 24, 2025

IDEAYA Biosciences, Inc. (IDYA) Presents at Citi's 2025 SMID Cap Biopharma Call Series Transcript

IDEAYA Biosciences, Inc. ( IDYA ) Citi's 2025 SMID Cap Biopharma Call Series November 6, 2025 12:00 PM EST Company Participants Yujiro Hata - Founder, President, CEO & Director Conference Call Participants Yigal Nochomovitz - Citigroup Inc., Research Division Presentation Yigal Nochomovitz Citigroup Inc., Research Division All right. Great. Hopefully, everyone is connected.

Seeking Alpha • Nov 7, 2025

IDEAYA Biosciences Reports Third Quarter 2025 Financial Results and Provides Business Update

Phase 2/3 trial (OptimUM-02) of the darovasertib/crizotinib combination in 1L HLA*A2-negative metastatic uveal melanoma (mUM) to report median PFS data by year-end 2025 to 1Q 2026; on track to complete enrollment by year-end 21.1 month median OS and 7.0 month median PFS reported from single-arm Phase 2 trial (OptimUM-01) evaluating the darovasertib/crizotinib combination in 1L mUM Phase 1 data reported in SCLC for IDE849 (DLL3 TOP1i ADC) at the World Conference on Lung Cancer.  Preliminary evidence of clinical efficacy was also observed in NETs patients, including Partial Responses by RECIST 1.1 Go-forward dose selected for IDE397 and Trodelvy® clinical combination in MTAP-deleted urothelial cancer (UC), and FPI achieved in non-small cell lung cancer (NSCLC); next clinical update planned for a medical conference in the first half of 2026 IND clearance for IDE892 (PRMT5) received in 3Q 2025; IND filing for IDE034 (B7H3/PTK7 bispecific TOP1i ADC) complete, with IND filing for IDE574 (KAT6/7) on track for year-end 2025 Entered into an exclusive license agreement with Servier for rights to darovasertib outside the United States; IDEAYA received $210 million upfront and is eligible for up to $320 million in milestone payments ~$1.14 billion of cash, cash equivalents, and marketable securities as of September 30, 2025; expected to fund operations into 2030 SOUTH SAN FRANCISCO, Calif.

PRNewsWire • Nov 4, 2025