Kura Oncology Announces FDA Approval for Ziftomenib

By Chris Stiles • Thursday, March 05 11:26 • Permanent Link

Kura Oncology, a clinical-stage biopharmaceutical company, has recently released its 10-K report. The company develops medicines for the treatment of cancer, with a lead product candidate, ziftomenib, targeting genetically defined subsets of acute leukemias and solid tumors. Kura Oncology has a clinical collaboration with Novartis Pharma AG, a strategic collaboration agreement with Kyowa Kirin Co., Ltd., and a clinical collaboration with Mirati Therapeutics, Inc.

In the 10-K report, under Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, Kura Oncology highlights the FDA approval of their NDA for ziftomenib, which is being marketed in the United States under the trade name KOMZIFTI. The company emphasizes the differentiated profile of KOMZIFTI, citing efficacy, safety, compatibility, and simplicity as key factors aligning with the priorities of physicians, pharmacists, and care teams treating patients with acute myeloid leukemia (AML).

The report also details the clinical development of ziftomenib in AML, including ongoing trials evaluating its combination with venetoclax and azacitidine, 7+3 chemotherapy, and quizartinib in newly diagnosed and relapsed or refractory AML. The company is also evaluating ziftomenib in combination with gilteritinib and FLAG-IDA or LDAC in patients with relapsed or refractory AML. Kura Oncology has completed enrollment of patients in several trials and expects to present updated data in the first and second halves of 2026.

Furthermore, the report mentions the commercial sales of KOMZIFTI in the United States, along with market access decisions and coverage policies by payors. KOMZIFTI has been added to the NCCN Guidelines® as a recommended treatment option for adults with relapsed or refractory NPM1-mutated AML. The company has submitted patent information for KOMZIFTI and is collaborating with Kyowa Kirin for commercialization and medical affairs activities in the United States.

Following these announcements, the company's shares moved -5.05%, and are now trading at a price of $8.46. For more information, read the company's full 10-K submission here.

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