Kura Oncology reported preliminary financial results, recent program achievements and a slate of expected milestones for 2026.
The company recorded $2.1 million in KOMZIFTI (ziftomenib) net product revenue during the five weeks of initial commercial availability that ended December 31, 2025. It received $195 million in milestone payments under its collaboration with Kyowa Kirin in the fourth quarter, and estimated non-cash collaboration revenue of $15 million to $17 million. Kura held $667.3 million in cash, cash equivalents and short-term investments at year-end 2025.
KOMZIFTI reached several regulatory and clinical milestones in 2025. In November the U.S. Food and Drug Administration granted full approval for adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring an NPM1 mutation, making KOMZIFTI the first once-daily oral menin inhibitor approved for that indication. The therapy was added to the National Comprehensive Cancer Network Clinical Practice Guidelines as a Category 2A treatment option.
Data presented at the American Society of Hematology Annual Meeting in December highlighted favorable safety and encouraging antileukemic activity for ziftomenib combined with venetoclax and azacitidine in patients with NPM1 mutations or KMT2A rearrangements, based on the ongoing KOMET-007 trial. Earlier in 2025 Kura initiated the Phase 3 KOMET-017 trial evaluating ziftomenib with intensive and non-intensive chemotherapy in newly diagnosed AML patients and presented farnesyl transferase inhibitor program data at the European Society for Medical Oncology Congress.
For 2026, Kura plans to accelerate U.S. uptake of KOMZIFTI in relapsed or refractory NPM1-mutated AML and pursue quarter-over-quarter revenue growth. The company expects to present updated KOMET-007 data on combinations with 7+3 chemotherapy in the first half of the year, publish data on the venetoclax/azacitidine combination, and share preliminary results from the KOMET-008 cohort evaluating ziftomenib with gilteritinib in the second half. Enrollment in the KOMET-017 Phase 3 trial will continue, and KOMET-007 cohorts will expand to explore additional combinations, including quizartinib. Kura also plans to evaluate ziftomenib beyond AML, including in gastrointestinal stromal tumors.
Development of darlifarnib will advance with expansion cohorts in advanced renal cell carcinoma expected to begin in the first half of 2026, and preliminary data anticipated from combinations with adagrasib in KRASG12C-mutated solid tumors. Updated dose-escalation data in RCC are expected in the second half of the year, alongside further exploration of new indications and combination strategies.
Kura’s pipeline will advance next-generation menin inhibitors, including KO-7246 in IND-enabling studies for diabetes and cardiometabolic diseases, and continue preclinical work on candidates for solid tumor therapy.
The company expects to recognize $45 million to $55 million in non-cash collaboration revenue in 2026. With $667.3 million in cash and investments at year-end 2025, plus anticipated collaboration payments and product revenue, Kura said it is well-positioned to support the ziftomenib AML program through topline results in the front-line Phase 3 trial.
Shares of Kura closed Friday at $9.41, down $0.14 or 1.47%, and traded at $9.69 in overnight trading at 11:31 PM EST, up $0.28 or 2.98%.
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