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Kura Oncology获得FDA批准白血病药物
2025-11-13 23:28
- The U.S. Food and Drug Administration on Thursday approved ziftomenib (Komzifti), a leukemia drug developed by Kura Oncology (KURA) with Japanese drugmaker Kyowa Kirin (OTCPK:KYKOF) (OTCPK:KYKOY), triggering a trading halt in the California-based biotech.
- In a press release, the FDA said it has approved the menin inhibitor for adults with relapsed or refractory acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) genetic mutation for whom satisfactory alternative treatments are not available.
- Previously, Kura’s (KURA) new drug application for ziftomenib was under the FDA’s priority review with a target action date of November 30.
- “Bolstered by a strong balance sheet and our productive partnership with Kyowa Kirin, we are well-positioned to advance ziftomenib toward commercialization,” CEO Troy Wilson said with the company’s Q3 results last week.
More on Kura Oncology, Kyowa Kirin
- Kura Oncology, Inc. (KURA) Q3 2025 Earnings Call Transcript
- Kura Oncology's Ziftomenib Poised For Differentiation
- Kura Oncology, Inc. (KURA) Discusses Clinical Updates on Farnesyl Transferase Inhibitor Programs and Combination Therapies in Oncology - Slideshow
- Kura Oncology outlines $315M near-term milestones as ziftomenib nears FDA decision and frontline trials expand
- Kura Oncology misses Q3 estimates
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