IDEAYA begins FDA application for uveal melanoma drug under fast-track program
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IDEAYA Biosciences to Initiate New Drug Application Submission from the Darovasertib OptimUM-02 Trial under the Oncology Center of Excellence Real-time Oncology Review (RTOR) Program
April 30, 2026 6:00 AM EDTPhase 2/3 registrational trial (OptimUM-02) of darovasertib combination met its primary endpoint and will be presented in a late-breaking oral presentation at ASCO 2026IDEAYA to initiate the RTOR submission process with the first pre-submission in May, with completion of the NDA filing expected in H2 '26
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