IDEAYA Biosciences, Inc. - 8-K Filing
IDEAYA Biosciences presented results from the Phase 2/3 OptimUM-02 trial of darovasertib in combination with crizotinib for first-line treatment of HLA*A2:01 negative metastatic uveal melanoma at ASCO on June 1, 2026. The drug combo showed a statistically significant improvement in median progression-free survival (PFS) by blinded independent central review (BICR), with 6.9 months versus 3.1 months for the control arm (HR: 0.42; p < 0.0001). IDEAYA expects to file an NDA under FDA's Real-Time Oncology Review program in H1 2026. (Items: 7.01 Regulation FD Disclosure, 8.01 Other Events, 9.01 Financial Statements and Exhibits)
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