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Kura Oncology Reports Fourth Quarter and Full Year 2025 Financial Results

KURA
  • Kura Oncology reported $2.1 million in net product revenue for the fourth quarter of 2025 following the November 13 FDA approval of KOMZIFTI (ziftomenib) for R/R NPM1-mutated AML.
  • The company received a $135 million milestone payment from Kyowa Kirin triggered by channel delivery within five business days of approval.
  • KOMZIFTI achieved rapid payer coverage with approximately 80% of private payers establishing published policies within 90 days, with no additional restrictions.
  • Patents for KOMZIFTI were listed in the FDA Orange Book extending exclusivity through July 2044.
  • The company initiated pivotal KOMET-017 Phase 3 trials for ziftomenib in the frontline AML setting, receiving $60 million in milestone payments from Kyowa Kirin for first patient dosing.
  • A Phase 1b dose expansion (FIT-001) for darlifarnib combined with cabozantinib was initiated for advanced renal cell carcinoma.
  • Kura Oncology holds a strong capital position of $667.2 million in cash, cash equivalents, & short-term investments as of December 31, 2025.
  • Anticipated collaboration payments of $180 million from Kyowa Kirin are expected to fund the ziftomenib AML program through topline Phase 3 results anticipated in 2028.
  • The company reported a net loss of $81.0 million for the fourth quarter of 2025, compared to $19.2 million in the same period of 2024.
  • Multiple clinical data milestones for AML & solid tumor programs are expected in 2026, including updated KOMET-007 data & preliminary data for darlifarnib combinations.
  • KOMZIFTI carries a Boxed Warning for Differentiation Syndrome, which can be fatal, requiring interruption of treatment & initiation of corticosteroids if suspected.
  • Safety warnings also include QTc interval prolongation & embryo-fetal toxicity risks associated with KOMZIFTI use.