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Ideaya Biosciences Moves Darovasertib Toward FDA Review After Positive Trial Readout

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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.

Price: $29.00, Change: $+0.95, Percent Change: +3.39%

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