Kura Oncology's NDA for ziftomenib accepted with Priority Review; Phase 2 shows 23% CR/CRh rate

Kura Oncology, Inc.

FDA accepted NDA for ziftomenib in R/R NPM1-m AML; Priority Review set; PDUFA date Nov 30, 2025.
Phase 2 KOMET-001: 23% (21/92) CR/CRh rate; median OS 16.4 months for responders, 3.5 months for non-responders.
63% of evaluable CR/CRh patients achieved MRD-negative; TRAEs led to discontinuation in 3% of patients.
Ziftomenib previously received Breakthrough Therapy, Fast Track, and Orphan Drug designations; co-developed with Kyowa Kirin.

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