Positive Trial Results for Ziftomenib
The KOMET-001 trial showed promising results for ziftomenib monotherapy in relapsed/refractory NPM1-mutated AML patients, with a CR/CRh rate of 23% and 63% of responders being MRD negative.
Regulatory Progress for Ziftomenib NDA
The FDA accepted the NDA for ziftomenib in relapsed/refractory NPM1-mutant AML, granting priority review with a PDUFA target action date of November 30, 2025.
Commercial Readiness for Ziftomenib Launch
Pre-commercial activities are underway to prepare for potential approval, including building commercial supply, advancing inspection readiness, and recruiting and training a sales force.
Financial Position and Collaboration Revenue
Kura reported $15.3 million in collaboration revenue from Kyowa Kirin and has $630.7 million in cash, cash equivalents, and short-term investments, which should fund operations into 2027.