On Thursday, the U.S. Food and Drug Administration granted full approval to Komzifti (ziftomenib), developed by Kura Oncology Inc. (NASDAQ:KURA) and Kyowa Kirin Co., Ltd., for treating relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation.
Komzifti is the first and only once-daily, oral menin inhibitor approved for R/R NPM1-mutated (NPM1-m) AML, a type of blood cancer. The approval is based on the pivotal KOMET-001 trial.
The rate of complete remission (CR) plus CR with partial hematologic recovery (CRh) was 21.4%.
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The median duration of CR+CRh was 5.0 months, and the median time to first response in patients who achieved a CR or CRh was 2.7 months. 88% of patients who achieved CR or CRh did so within 6 months of initiating Komzifti.
In November 2024, Kura Oncology and Kyowa Kirin entered into a global strategic collaboration to develop and commercialize Komzifti.
In October, Kura Oncology confirmed a $30 million milestone payment from its collaboration with Kyowa Kirin.
The payment followed the first patient dosing in the KOMET-017 Phase 3 registrational study for ziftomenib, a novel oral menin inhibitor under development for acute myeloid leukemia (AML).
Kura ended the September quarter with $609.7 million in pro forma cash, together with anticipated collaboration payments, expected to support the ziftomenib AML program through topline results in KOMET-017.
Wedbush maintains Kura Oncology with an Outperform and raises the price target from $36 to $38.
Price Action: KURA stock was trading higher by 15.07% to $12.29 at last check Friday.
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