Kura Oncology reported results and updates in an SEC Form 8-K filing, detailing early commercial revenue for its newly launched product KOMZIFTI, recent clinical progress and anticipated milestones for 2026.
For the period from November 21, 2025, through December 31, 2025, Kura recorded $2.1 million in net product revenue from KOMZIFTI. The company also received $195 million in milestone payments under its collaboration with Kyowa Kirin. Collaboration revenue for the fourth quarter of 2025 is estimated at $15 million to $17 million. Cash, cash equivalents and short-term investments totaled $667.3 million as of December 31, 2025.
KOMZIFTI received FDA approval for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation and is the first and only once-daily, oral menin inhibitor approved for this indication. The treatment was added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology as a Category 2A recommended option.
In December 2025, Kura presented favorable safety and efficacy data for ziftomenib in combination with venetoclax and azacitidine at the American Society of Hematology Annual Meeting. The company also initiated a Phase 3 trial evaluating ziftomenib combined with chemotherapy regimens for newly diagnosed AML patients.
Kura said it will focus on accelerating U.S. uptake of KOMZIFTI and driving quarter-over-quarter growth in net product revenue, while advancing its pipeline programs, including next-generation menin inhibitors and farnesyl transferase inhibitors, and presenting updated clinical data.
President and CEO Troy Wilson, Ph.D., J.D., expressed confidence in the commercial launch strategy for KOMZIFTI, citing its efficacy, safety profile and ease of use, and said the company is positioned to deliver meaningful impact for patients in 2026 and beyond.
Kura expects to recognize $45 million to $55 million of non-cash collaboration revenue in 2026. The company said its cash position, together with anticipated collaboration payments and product revenue, should support the ziftomenib AML program through topline results from the front-line Phase 3 trial for newly diagnosed AML.
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