Kura Oncology, Inc.

Kura Oncology, Inc. (NASDAQ: KURA) is a biopharmaceutical company committed to developing precision medicines for the treatment of cancer. Founded in 2014, the company has evolved from a research and development organization into a fully-integrated commercial-stage enterprise with a diversified pipeline of small molecule product candidates designed to target cancer signaling pathways and address significant unmet needs in oncology and hematology. The company's website is www.kuraoncology.com.

In November 2025, Kura achieved a major milestone with FDA approval of KOMZIFTI (ziftomenib), marking the company's transition to a commercial organization. KOMZIFTI is approved for treating adults with relapsed or refractory acute myeloid leukemia with susceptible nucleophosmin 1 mutations who have no satisfactory alternative treatment options. The drug represents the first and only menin inhibitor approved by the FDA for once-daily oral administration and is differentiated by its efficacy, safety profile, compatibility with other medications, and simplified dosing regimen. The company initiated commercial sales in the United States on November 21, 2025.

Kura's pipeline extends beyond its lead product to include multiple development programs. The company is advancing ziftomenib across the AML treatment continuum, including in newly diagnosed disease and in combination with various standards of care. Ziftomenib is also being evaluated for gastrointestinal stromal tumors in combination with imatinib. Additionally, Kura is exploring KO-7246, a next-generation menin inhibitor, for diabetes and cardiometabolic disorders, and developing farnesyl transferase inhibitors, particularly darlifarnib, in combination with targeted therapies for solid tumors including renal cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma.

The company employs a precision medicine approach, utilizing translational research, patient-derived xenograft models, and companion diagnostics to identify patient populations most likely to benefit from its product candidates. Under a collaboration agreement with Kyowa Kirin, Kura leads U.S. commercial strategy and manufacturing while sharing profits and losses equally on U.S. commercialization activities. Outside the United States, Kyowa Kirin handles commercial strategy and sales booking. The company estimates the initial U.S. market opportunity for relapsed or refractory NPM1-mutated AML at approximately $350 to $400 million annually, with a total addressable market across all AML treatment settings estimated at approximately $7 billion.