11:44 AM EST, 11/13/2025 (MT Newswires) -- Kura Oncology ( KURA ) and Kyowa Kirin said Thursday the US Food and Drug Administration approved Komzifti for adults with relapsed or refractory acute myeloid leukemia carrying an NPM1 mutation.

The approval is based on a study of 112 patients, in which about 21% achieved complete remission or complete remission with partial hematologic recovery, with a median duration of response of five months

The release said the therapy showed no meaningful drug interaction issues and low rates of QTc prolongation, including in older adults.

Kura and Kyowa Kirin entered a global collaboration in November 2024 to codevelop and commercialize Komzifti, with Kura leading development and commercialization in the US and Kyowa Kirin managing markets outside the US.

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