05:54 AM EDT, 06/02/2025 (MT Newswires) -- Kura Oncology ( KURA ) and Kyowa Kirin said Sunday that the US Food and Drug Administration has accepted Kura's new drug application seeking full approval for ziftomenib to treat relapsed or refractory acute myeloid leukemia in adult patients.

The company said the agency granted the application priority review and assigned a prescription drug user fee act target action date of Nov. 30.

The application is based on positive results from a phase 2 trial in patients with relapsed or refractory acute myeloid leukemia with a nucleophosmin 1 mutation. Kura said the trial achieved its primary endpoint, which was "statistically significant."

Acute myeloid leukemia is a cancer of the myeloid line of blood cells.

The company's shares were up 14% in recent premarket activity Monday.