From Nasdaq: 2025-06-01 21:13:00

Kura Oncology Inc. and Kyowa Kirin Co., Ltd. have submitted a New Drug Application seeking full approval for ziftomenib as a treatment for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a nucleophosmin 1 mutation. The FDA has accepted the application for Priority Review with a target action date of November 30, 2025. The NDA is based on positive results from the Phase 2 KOMET-001 trial, where ziftomenib showed effectiveness in treating R/R NPM1-mutant AML with limited side effects. The benefit-risk profile for ziftomenib is promising.



Read more at Nasdaq: FDA Reviews Kura’s NDA For Ziftomenib To Treat Acute Myeloid Leukemia With NPM1 Mutation