From GlobeNewswire: 2025-06-01 19:00:00

Kura Oncology and Kyowa Kirin announced that the FDA has accepted the New Drug Application for ziftomenib, a potential treatment for adult patients with relapsed or refractory AML with an NPM1 mutation. The application has been granted Priority Review, with a target action date of November 30, 2025. The drug showed positive results in the Phase 2 KOMET-001 trial, meeting its primary endpoint of complete remission. If approved, ziftomenib could be the first menin inhibitor for this type of AML, offering hope to patients with limited treatment options. The full data analysis will be presented at upcoming oncology conferences.



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