Kura Oncology KURA · USD

We are a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Since our founding in 2014, we have transformed from a research and development company to a fully-integrated commercial-stage organization with a diversified pipeline of product candidates. Our pipeline consists of small molecules designed to target cancer signaling pathways and address significant unmet needs in oncology and hematology.

2025 was a pivotal year for our company. On November 13, 2025, the FDA approved our new drug application, or NDA, for ziftomenib, which is being marketed in the United States under the trade name KOMZIFTITM, for the treatment of adults with relapsed or refractory acute myeloid leukemia, or AML, with a susceptible nucleophosmin 1, or NPM1, mutation who have no satisfactory alternative treatment options. KOMZIFTI is the first and only menin inhibitor approved by the FDA for once-daily oral administration.

We continue to evaluate ziftomenib across the AML treatment continuum, including in relapsed or refractory and newly diagnosed disease and in patient subtypes representing up to 50% of AML cases. Among other studies, our clinical development program includes two registrational Phase 3 clinical trials of ziftomenib in combination with intensive and non-intensive chemotherapy in patients with newly diagnosed AML and multiple clinical trials of ziftomenib in combination with standards of care in patients with relapsed or refractory and newly diagnosed AML with NPM1 and FLT3 co-mutations.

Quoted from its 10-K, filed 5 Mar 2026. Read the filing on SEC.gov ↗