FDA Grants Priority Review for Kura Oncology, Inc. (KURA) and Kyowa Kirin’s Ziftomenib

The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for ziftomenib, an investigational treatment pursued by Kura Oncology, Inc. (NASDAQ:KURA) and Kyowa Kirin, and assigned it a Priority Review. The agency set a Prescription Drug User Fee Act (PDUFA) target action date for November 30, 2025.

A biopharmaceutical researcher intently studying results from a clinical trial.

San Diego-based company, Kura Oncology, Inc. (NASDAQ:KURA) specializes in precision oncology with a pipeline centered on small-molecule inhibitors. The company formed a global collaboration with Kyowa Kirin in late 2024 to jointly develop ziftomenib, a treatment for relapsed or refractory NPM1-mutant acute myeloid leukemia (AML). In April 2024, the company strengthened the drug‘s regulatory compliance by earning the Breakthrough Therapy Designation from the FDA.

The announcement of FDA’s approval for Priority Review follows positive results from the Phase 2 KOMET-001 trial, which met its primary endpoint, achieving notable rates of complete remission or partial hematologic recovery in a high-risk patient cohort.

With limited treatment-related discontinuations, ziftomenib has demonstrated a favorable safety profile. If approved, ziftomenib would be the first FDA-sanctioned menin inhibitor specifically developed for this genetically defined AML subgroup, thus potentially becoming a landmark development in hematologic oncology.

CEO of Kura Oncology, Inc. (NASDAQ:KURA), Troy Wilson, made the following comment:

“FDA’s acceptance of our New Drug Application marks a significant milestone for Kura and Kyowa Kirin and, more importantly, for patients living with this genetic subset of AML.”

On May 19, 2025, a few days before the announcement, Mizuho analyst Mara Goldstein adjusted the price target for the company from USD 32.00 to USD 30.00, while maintaining the Outperform rating, signaling a cautious approach.

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Disclosure: None.