IDEAYA Achieves Complete Enrollment in Key Trial of Darovasertib for Metastatic Uveal Melanoma
Trial Enrollment Completion: IDEAYA Biosciences has completed the enrollment of 435 patients in its OptimuUM-02 Phase 2/3 trial, which evaluates the combination of Darovasertib and Pfizer's Crizotinib for treating HLA*A2-negative metastatic uveal melanoma (mUM).
Urgent Need for New Therapies: Metastatic uveal melanoma is a rare and aggressive cancer with poor survival rates, highlighting the necessity for innovative treatment options, as current therapies are limited.
Promising Early Results: Previous results from the OptimUM-01 trial indicated a median overall survival of 21.1 months and a median progression-free survival of 7.0 months, suggesting the potential effectiveness of the Darovasertib and Crizotinib combination.
Regulatory Designations and Stock Performance: Darovasertib has received multiple FDA designations, including Breakthrough Therapy and Fast Track, while IDEAYA's stock is currently trading at $35.60, reflecting a 5.83% increase in pre-market trading.
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IDEAYA Biosciences Updates 2026 Corporate Objectives at J.P. Morgan Conference
- Pipeline Advancement: In 2025, IDEAYA successfully advanced multiple clinical projects, filing four INDs resulting in nine clinical programs, demonstrating the company's strong execution and readiness in the precision medicine oncology sector.
- Key Trial Plans: In 2026, IDEAYA plans to advance four registrational trials, including IDE849 as a monotherapy for neuroendocrine cancer and darovasertib for both pre-metastatic and metastatic uveal melanoma, aiming to improve patient prognosis and quality of life.
- Funding Assurance: The company expects its cash runway to support operations into 2030, ensuring the continued advancement of key combination therapies in high unmet need cancer areas, thereby enhancing its market competitiveness.
- Strategic Vision: IDEAYA is committed to developing targeted cancer therapies, particularly in the uveal melanoma space where FDA-approved treatments are lacking, showcasing its leadership and innovative potential in precision oncology.

IDEAYA Biosciences Updates 2026 Strategic Objectives, Plans to Advance Four Registrational Trials
- Advancement of Registrational Trials: IDEAYA plans to advance four registrational trials in 2026, including darovasertib for uveal melanoma, aimed at improving patient prognosis and addressing the lack of FDA-approved therapies.
- Clinical Data Release: Topline PFS data from the darovasertib and crizotinib combination is expected in Q1 2026, and if positive, will support a potential accelerated approval filing in the U.S., enhancing market competitiveness.
- Financial Assurance: As of September 30, 2025, IDEAYA has approximately $1.1 billion in cash and cash equivalents, expected to fund its operating plan into 2030, ensuring ongoing investment in R&D.
- New Drug Development: The company plans to initiate a registrational study for IDE849 targeting small cell lung cancer and neuroendocrine carcinomas by the end of 2026, showcasing its ongoing innovation in precision medicine.








