11:08 AM EDT, 04/30/2026 (MT Newswires) -- Ideaya Biosciences ( IDYA ) said the US Food and Drug Administration agreed to review its new drug application for darovasertib in combination with crizotinib for patients with first-line HLA*A2-negative metastatic uveal melanoma under the agency's Oncology Center of Excellence Real-Time Oncology Review program.

The phase 2/3 trial of darovasertib in combination with crizotinib met its primary endpoint, lowering the risk of disease progression by 58% and achieving a statistically significant improvement in median progression-free survival of 6.9 months, Ideaya said Thursday in a statement.

The company plans to begin submitting portions of its application in May and expects to complete the full filing in the H2.

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