Kura Oncology Soars 15.11% on FDA NDA Acceptance for AML Drug

On June 2, 2025, Kura Oncology's stock surged by 15.11% in pre-market trading, marking a significant rise that has caught the attention of investors and analysts alike.

Kura Oncology and its partner Kyowa Kirin have announced that the U.S. Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for ziftomenib. This drug is intended for adult patients with relapsed or refractory acute myeloid leukemia (AML) who have an NPM1 mutation. The FDA has granted priority review status to the application, which is a positive indicator of the potential efficacy and importance of the treatment.

The acceptance of the NDA by the FDA is a crucial milestone for Kura Oncology, as it brings the company one step closer to potentially bringing a new treatment option to patients with a specific type of AML. The priority review status further underscores the FDA's recognition of the unmet medical need in this patient population and the potential of ziftomenib to address it.

This development has likely contributed to the positive market sentiment surrounding Kura Oncology, as investors anticipate the potential approval and commercialization of ziftomenib. The company's focus on developing targeted therapies for cancer patients continues to drive its growth and innovation in the oncology space.