Positive Data from KOMET-001 Trial
Ziftomenib showed promising results in relapsed or refractory NPM1-mutated AML with a CR/CRh rate of 23% and 63% of responders being MRD negative.
FDA Priority Review
FDA accepted the NDA for ziftomenib with a PDUFA target action date of November 30, 2025, indicating positive regulatory progress.
Strong Financial Position
Kura Oncology has $630.7 million in cash, cash equivalents, and short-term investments, sufficient to fund operations into 2027.
Advancements in Pipeline
Progress with next-generation farnesyl transferase inhibitor, KO-2806, with three clinical abstracts accepted for presentation at the 2025 ESMO Congress.
Commercial Readiness for Ziftomenib
Preparations for potential approval are underway, including the building of commercial supply, quality systems, and a sales force.