Kura Oncology NASDAQ: KURA reported second-quarter net product revenue of $9.1 million from KOMZIFTI, its treatment for relapsed or refractory NPM1-mutated acute myeloid leukemia, as the company said the drug captured a majority share of new patient starts in the menin inhibitor market for that indication.
The company recorded approximately 115 new patient starts and more than 250 total prescriptions during the quarter. Chief Commercial Officer Brian Powl said new patient starts increased about 35% sequentially, while total prescriptions rose about 60% from the prior quarter. He said the prescription growth reflected both repeat prescribing and new prescriptions, without meaningful contributions from inventory stocking or other one-time events.
“KOMZIFTI moved into a leadership position in relapsed refractory NPM1-mutated AML menin inhibitor market,” President and Chief Executive Officer Troy Wilson said during the earnings call. Kura entered the market after a competitor but said its early share performance indicated that physicians are differentiating among therapies in the class.
Commercial launch and market access
Kura said KOMZIFTI adoption expanded across academic and community treatment centers, while repeat prescribing increased and additional accounts began using menin inhibitor therapy. Powl said the company engaged with more than 90% of its top-priority AML accounts during the quarter.
Physician-initiated combination use of KOMZIFTI with venetoclax and azacitidine, as well as with FLT3 inhibitors in patients with co-mutations, represented about 40% of new patient starts. The company promotes the product for its approved monotherapy indication, but management said the combination prescribing activity suggests clinicians see potential for the drug alongside other AML treatments.
Kura said more than 95% of covered lives have access to KOMZIFTI, with no label restrictions. Powl added that approximately 16 million covered lives have preferred status that requires patients to step through KOMZIFTI before receiving other menin inhibitors. He said prior authorization requirements have not created material access challenges for prescribers.
During the question-and-answer session, Wilson said Kura’s claim of majority share applies specifically to new patient starts in NPM1-mutated AML. He said the company’s 115 new patient starts compared with an estimated 100 NPM1-related starts for its competitor, based on that company’s reported total patient starts and stated mix of NPM1 patients.
Ziftomenib clinical development
Kura is pursuing a broader development strategy for ziftomenib, the active ingredient in KOMZIFTI, in AML combination regimens and earlier treatment settings. Chief Medical Officer Mollie Leoni highlighted results from the KOMET-007 study of ziftomenib plus venetoclax and azacitidine in relapsed or refractory disease, which were published in Blood before the European Hematology Association meeting.
Among venetoclax-naive patients in that study, Kura reported an 87% overall response rate, a 70% complete remission or complete remission with incomplete hematologic recovery rate, and median overall survival not reached at nearly 11 months of follow-up.
At EHA, the company presented long-term data from KOMET-007 evaluating ziftomenib plus 7+3 chemotherapy in 99 patients with newly diagnosed NPM1-mutated and/or KMT2A-rearranged AML. Leoni said the data showed high remission rates and deep responses. The company reported a 96% overall response rate in relapsed or refractory NPM1-mutated AML, 94% overall survival at 12 months, and median overall survival not reached after a median follow-up of 17.6 months.
Leoni said ziftomenib did not appear to add meaningful myelosuppression to intensive chemotherapy. Kura believes the dataset is the largest frontline intensive-chemotherapy dataset reported for a menin inhibitor.
The pivotal KOMET-017 trial, which includes intensive and non-intensive chemotherapy settings, is enrolling across the U.S., Europe and Asia. Kura said it expects more than 200 sites to be active as enrollment progresses and continues to anticipate top-line results in 2028.
The company also expects preliminary data later this year for ziftomenib plus gilteritinib in relapsed or refractory NPM1- and FLT3-mutated AML. It also plans to provide data in the second half of 2026 from a regimen combining ziftomenib, 7+3 chemotherapy and quizartinib, along with updated venetoclax/azacitidine data and an exploratory analysis in other menin-dependent AML subtypes.
Darlifarnib program advances in solid tumors
Kura also discussed darlifarnib, a wholly owned precision-oncology asset being developed in combination with targeted therapies. In patients with renal cell carcinoma previously exposed to cabozantinib, darlifarnib plus cabozantinib produced a 44% objective response rate and 94% disease control rate, according to the company.
In 34 cabozantinib-naive patients with advanced clear-cell renal cell carcinoma, objective response rates ranged from 33% to 50% across dose levels, and median progression-free survival was 13 months. Kura said the combination’s safety profile was manageable.
The randomized phase 1b portion of the FIT-001 study is comparing darlifarnib plus cabozantinib with cabozantinib alone in cabozantinib-naive clear-cell renal cell carcinoma. Kura expects enrollment to finish in the first half of 2027 and initial data in the second half of that year.
Separately, first-in-human data presented at ASCO for darlifarnib plus adagrasib showed tumor shrinkage in 77% of response-evaluable patients with KRAS G12C-mutated cancers. Kura plans to begin a platform study of darlifarnib plus daraxonrasib in second-line or later KRAS-mutant pancreatic cancer in the first half of 2027.
Financial results and outlook
- Collaboration revenue from Kyowa Kirin was $11.8 million, down from $15.3 million a year earlier.
- Research and development expense was $61.9 million, compared with $62.8 million in the prior-year quarter.
- Selling, general and administrative expense rose to $31.8 million from $25.2 million.
- Net loss was $68.3 million, compared with a $66.1 million loss in the second quarter of 2025.
- Cash equivalents and short-term investments totaled $519 million as of June 30, down from $667.2 million at year-end 2025.
Kura maintained its guidance for collaboration revenue of $45 million to $55 million in 2026, $90 million to $110 million in 2027, and $90 million to $110 million in 2028. The company said its cash balance, together with anticipated $180 million in payments under its Kyowa Kirin collaboration, is expected to fund the ziftomenib AML program through the first anticipated phase 3 KOMET-017 top-line results in 2028.
About Kura Oncology (NASDAQ:KURA)
Kura Oncology, Inc NASDAQ: KURA is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted oncology therapies. Headquartered in La Jolla, California, the company leverages expertise in molecular biology and precision medicine to identify key drivers of cancer growth and design small-molecule inhibitors that block those pathways. Kura's research platform integrates genomic insights with medicinal chemistry to advance candidates against well-validated targets in solid tumors and hematologic malignancies.
The company's lead clinical candidate, tipifarnib, is a farnesyltransferase inhibitor being evaluated for the treatment of HRAS-mutant head and neck squamous cell carcinoma and various non-small cell lung cancers.
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