SOUTH SAN FRANCISCO, Calif. – IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company, has laid out its strategic roadmap for 2026, signaling a pivotal year for pipeline advancement and potential regulatory milestones. The company is poised to present these key objectives at the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026.
“2025 was a year of significant execution, characterized by broad pipeline progress, commercial preparation for darovasertib, and the successful filing of four INDs, leading to nine clinical programs,” stated Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences. “Our robust pipeline and substantial cash runway extending into 2030 empower IDEAYA to accelerate the development of key combination therapies and target multiple indications with high unmet needs. This includes challenging areas such as uveal melanoma, small cell lung cancer, neuroendocrine cancer, breast cancer, and MTAP-deleted lung, pancreatic, and urothelial cancers. In 2026, we are focused on advancing four registrational trials. Notably, this includes IDE849, our Phase 1 DLL3 TOP1 ADC, as a monotherapy for neuroendocrine cancer, and darovasertib in both pre-metastatic and metastatic uveal melanoma. These trials for darovasertib are central to our strategy to improve outcomes, preserve vision, and extend lives for patients with uveal melanoma, an indication with one of the poorest prognoses in oncology where a significant majority of patients currently lack FDA-approved therapies.”
**Key Corporate Objectives for 2026**
**Darovasertib in Uveal Melanoma (UM)**
* **OptimUM-02 Trial:** Topline results, including progression-free survival (PFS) data, from the ongoing registrational Phase 2/3 OptimUM-02 trial evaluating the combination of darovasertib and crizotinib in first-line (1L) patients with HLA*A2-negative metastatic UM (mUM) are anticipated in Q1 2026. The randomized PFS analysis will be based on the first 130 PFS events from the intent-to-treat (ITT) population enrolled in the Phase 2b/3 portion of the trial, comprising approximately 313 patients randomized 2:1 to either the treatment or control arm. Positive topline PFS results could support a potential accelerated approval filing in the United States.
* **Phase 3 Expansion:** By H1 2026, darovasertib is expected to be evaluated in three randomized, Phase 3 registrational trials across all stages of uveal melanoma.
* **OptimUM-02 (mUM):** Full enrollment of 437 patients is complete. Overall survival (OS) data from this trial are expected to support a filing for full approval in 1L HLA*A2-negative mUM.
* **OptimUM-10 (Neoadjuvant):** Full enrollment of approximately 450 patients across enucleation and plaque brachytherapy cohorts is targeted for completion by H1 2027.
* **OptimUM-11 (Adjuvant):** This trial, conducted in collaboration with Servier, is slated to initiate in Q2 2026.
* **OptimUM-01 Trial:** Enrollment of approximately 80 HLA*A2-positive mUM patients in the ongoing single-arm, Phase 2 OptimUM-01 trial of darovasertib in combination with crizotinib is expected to be completed by Q2 2026. Data from this trial are intended to support a potential real-world evidence (RWE) submission to the U.S. Food and Drug Administration (FDA) and/or NCCN/compendia listing for this patient subset.
**Antibody-Drug Conjugate (ADC) + DNA Damage Response (DDR) Combinations**
* **IDE849 (DLL3 TOP1 ADC):** The company aims to initiate a monotherapy registrational study in the second-line/refractory setting (2L+) of small cell lung cancer (SCLC) and/or neuroendocrine carcinomas (NEC) by the end of 2026.
* **IDE034 (B7H3/PTK7 bispecific TOP1 ADC):** A Phase 1 dose escalation trial is scheduled to commence in Q1 2026.
* **IDE161 (PARG):** Clinical combination studies with IDE849 in SCLC, NEC, and other DLL3-overexpressing solid tumors are planned to begin in Q2 2026.
**MTAP Pathway**
* **IDE397 (MAT2A):** Updated data from the Phase 1/2 combination trial with Trodelvy in MTAP-deleted urothelial cancer (UC) will be presented at a medical conference in 2026.
* **IDE892 (PRMT5):** A Phase 1 monotherapy dose escalation trial is set to initiate in Q1 2026, paving the way for a combination trial with IDE397 in MTAP-deleted non-small cell lung cancer (NSCLC) in Q2 2026.
* **CDKN2A Targeting:** An investigational new drug (IND) application for a potential first-in-class program targeting CDKN2A, the most common co-alteration with MTAP, is planned for submission by the end of 2026. IDEAYA intends to leverage this candidate for wholly owned combinations with IDE892 and IDE397 in MTAP-deleted NSCLC and pancreatic ductal adenocarcinoma (PDAC), as well as with IDE574, IDEAYA’s dual KAT6/7 inhibitor.
**Next Generation Therapies**
* **IDE574 (KAT6/7):** The company received IND clearance from the U.S. FDA in January 2026, with a Phase 1 dose escalation trial targeted for initiation in Q1 2026.
**Corporate and Financial Update**
IDEAYA Biosciences reported approximately $1.1 billion in cash, cash equivalents, and marketable securities as of September 30, 2025, a financial position expected to fund its current operating plan through 2030. Commercial readiness activities for darovasertib are progressing in the United States and globally in partnership with Servier.
An updated corporate presentation detailing IDEAYA’s 2026 corporate guidance is available in the Investor Relations section of the company’s website.
**About IDEAYA Biosciences**
IDEAYA Biosciences is a precision medicine oncology company dedicated to the discovery, development, and commercialization of transformative cancer therapies. The company’s strategy integrates expertise in small-molecule drug discovery, structural biology, and bioinformatics with robust capabilities in identifying and validating translational biomarkers. This approach aims to develop tailored, potentially first-in-class targeted therapies aligned with the genetic drivers of disease. IDEAYA has built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates (ADCs) for molecularly defined solid tumor indications, with the goal of delivering more selective, effective, and personalized treatments to improve clinical outcomes for cancer patients.
**Forward-Looking Statements**
This press release contains forward-looking statements regarding the potential therapeutic benefits of IDEAYA’s therapeutics, the timing and content of clinical program updates, regulatory milestones, data readouts, potential accelerated approval filings for darovasertib, the progression of darovasertib trials, the use of OS data for full approval filings, the initiation timelines for registrational studies and other clinical trials, patient enrollment projections, IND submission timelines, and the extent to which current cash reserves will fund the operating plan. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a comprehensive description of risks and uncertainties that could cause actual results to differ from those projected, please refer to IDEAYA’s filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K filed on February 18, 2025.
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