(RTTNews) – Kura Oncology Inc. reported preliminary 2025 results, recent program achievements and key milestones planned for 2026.
The company recorded $2.1 million in KOMZIFTI (ziftomenib) net product revenue during the five weeks of initial commercial availability that ended Dec. 31, 2025. Kura also received $195 million in milestone payments from its collaboration with Kyowa Kirin in the fourth quarter, and estimates non-cash collaboration revenue of $15 million to $17 million for the period.
Kura held $667.3 million in cash, cash equivalents and short-term investments at year-end 2025.
KOMZIFTI achieved 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 ziftomenib the first and only once-daily oral menin inhibitor approved for this indication. The therapy was added to the National Comprehensive Cancer Network Clinical Practice Guidelines as a Category 2A recommended option.
At the American Society of Hematology annual meeting in December, Kura presented oral data from the ongoing KOMET-007 trial showing favorable safety and encouraging antileukemic activity for ziftomenib combined with venetoclax and azacitidine in patients with NPM1 mutations or KMT2A rearrangements. Earlier in 2025 the company launched the Phase 3 KOMET-017 trial evaluating ziftomenib with intensive and non-intensive chemotherapy in newly diagnosed AML and presented data from its farnesyl transferase inhibitor programs at the ESMO Congress.
For 2026, Kura plans to accelerate U.S. uptake of KOMZIFTI in relapsed or refractory NPM1‑mutated AML and drive 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 report 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, alongside expansion of KOMET-007 cohorts to explore additional combinations such as quizartinib. Kura also plans to evaluate ziftomenib beyond AML, including studies in gastrointestinal stromal tumors.
Development of darlifarnib remains a priority. Expansion cohorts in advanced renal cell carcinoma are expected to begin in the first half of 2026, with preliminary data from combinations with adagrasib in KRASG12C‑mutated solid tumors anticipated. Updated dose‑escalation data in RCC are expected in the second half, along with exploration of new indications and combination strategies.
Kura will also advance next‑generation menin inhibitors, including KO-7246, which is in IND‑enabling studies for diabetes and cardiometabolic diseases, and continue preclinical work on candidates for solid tumors.
The company expects to recognize $45 million to $55 million in non‑cash collaboration revenue in 2026. With $667.3 million in year‑end cash and investments, plus anticipated collaboration payments and product revenue, Kura said it is well positioned to support the ziftomenib AML program through topline results from the front‑line Phase 3 trial in newly diagnosed AML.
Kura shares closed Friday at $9.41, down $0.14, or 1.47%. In overnight trading at 11:31 p.m. EST the shares were $9.69, up $0.28, or 2.98%.
The views and opinions expressed herein are those of the author and do not necessarily reflect those of Nasdaq, Inc.
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