Darovasertib combo trial meets primary endpoint, IDEAYA plans NDA filing in H2 2026 with strong cash position.

IDEAYA Biosciences announced positive topline results from the Phase 2/3 OptimUM-02 trial of darovasertib combined with crizotinib for first-line HLA*A2-negative metastatic uveal melanoma, showing a 58% reduction in disease progression risk and improved progression-free survival. The company plans to submit a New Drug Application (NDA) to the FDA in the second half of 2026, aiming for accelerated approval under the Real-Time Oncology Review program. Additional clinical updates for other pipeline candidates are expected in H2 2026, and IDEAYA maintains a strong cash reserve of approximately $973 million, supporting operations into 2030.