Kura Oncology, Inc. (KURA) recently reported second-quarter 2026 financial results, highlighted by strong commercial momentum for KOMZIFTI (ziftomenib) and continued progress across its AML and solid tumor pipeline.
KOMZIFTI (ziftomenib) is Kura Oncology's FDA-approved, once-daily oral menin inhibitor for adults with relapsed or refractory NPM1-mutated acute myeloid leukemia (AML).
The U.S. FDA granted full approval to KOMZIFTI on November 13, 2025, for this indication.
KOMZIFTI (ziftomenib) generated $9.1 million in net product revenue in Q2 2026, up 57% compared with no net product revenue in Q2 2025.
The company recorded approximately 115 new patient starts, a 35% sequential increase, while total prescriptions exceeded 250, representing a 59% increase from the prior quarter.
After only two full quarters of launch, KOMZIFTI captured a majority share of new patient starts in the relapsed/refractory NPM1-mutated AML menin inhibitor class, establishing early commercial leadership.
Advancing Ziftomenib Across AML
Kura continues to expand ziftomenib into earlier lines of AML treatment and into combination regimens.
The long-term data from the Phase 1a/b KOMET-007 study, presented at the EHA 2026, demonstrated durable activity with ziftomenib in combination with intensive chemotherapy in adults with newly diagnosed acute myeloid leukemia (AML) harboring NPM1 mutations or KMT2A rearrangements who are eligible for intensive chemotherapy with the 7+3 regimen.
The regimen produced complete remission composite rates of 96% and 90%, respectively, with 12-month overall survival rates of 94% and 71%.
Updated Phase 1a/b KOMET-007 study results also demonstrated strong responses with ziftomenib plus venetoclax and azacitidine in relapsed/refractory NPM1-mutated AML.
Venetoclax-naïve patients achieved an 87% overall response rate and a 70% CRc rate, with 75% of complete responders achieving central MRD negativity.
Kura is continuing enrollment in the KOMET-017 Phase 3 randomized, double-blind, placebo-controlled trials, evaluating ziftomenib in the frontline setting for adults with newly diagnosed acute myeloid leukemia (AML).
The company is also advancing studies of ziftomenib in combination with gilteritinib and quizartinib in genetically defined AML populations.
2026 Ziftomenib Catalysts
Kura expects several clinical updates in the second half of 2026, including:
Long-term KOMET-007 (Phase 1b) data for ziftomenib plus venetoclax/azacitidine in newly diagnosed NPM1-mutated AML patients ineligible for intensive chemotherapy.
Initial KOMET-007 (Phase 1b/2) data for ziftomenib plus 7+3 chemotherapy and quizartinib in newly diagnosed NPM1-mutated/FLT3-ITD AML.
Initial KOMET-008 (Phase 1a/b) data evaluating ziftomenib plus gilteritinib in relapsed/refractory NPM1-mutated/FLT3-mutated AML.
Exploratory KOMET-001 (Phase 1) data assessing ziftomenib monotherapy in MEIS1-associated AML subtypes beyond NPM1-mutated and KMT2A-rearranged disease.
Darlifarnib Advances As Precision Combination Platform
Kura is also developing darlifarnib as a potential precision combination therapy across solid tumors.
In KRAS G12C-mutated solid tumors, Phase 1 FIT-001 data for darlifarnib plus adagrasib demonstrated tumor shrinkage in 77% of response-evaluable patients, with confirmed ORRs of 67% in pancreatic cancer, 50% in non-small cell lung cancer and 29% in KRAS inhibitor-naïve colorectal cancer.
In clear cell renal cell carcinoma, darlifarnib plus cabozantinib produced ORRs of up to 50% in cabozantinib-naïve patients, with a median progression-free survival of 13 months.
Among patients previously exposed to cabozantinib, the combination achieved a 44% ORR, 94% disease control rate and tumor shrinkage in 75% of patients, supporting further evaluation of darlifarnib as a strategy to overcome resistance to VEGFR-targeted therapy.
The randomized FIT-001 Phase 1b study comparing darlifarnib plus cabozantinib with cabozantinib alone is ongoing in cabozantinib-naïve clear cell RCC.
Financial Results
Kura reported $9.1 million in net product revenue for the second quarter of 2026, compared with no product revenue in the year-ago quarter.
Collaboration revenue was $11.8 million, compared with $15.3 million in Q2 2025.
R&D expenses totaled $61.9 million, compared with $62.8 million in Q2 2025.
SG&A expenses increased to $31.8 million from $25.2 million in Q2 2025.
Net loss was $68.3 million or $0.77 per share, compared with $66.1 million or $0.75 per share in the second quarter of 2025.
Cash Position
As of June 30, 2026, Kura had $519.0 million in cash, cash equivalents and short-term investments.
Including approximately $180 million in anticipated collaboration payments from Kyowa Kirin, Kura expects its available resources to fund the ziftomenib AML program through topline results from the first pivotal Phase 3 KOMET-017 trial, anticipated in 2028.
Beyond AML, Kura plans to continue developing ziftomenib in additional indications while advancing darlifarnib across multiple targeted therapy combinations.
The company also plans to move its next-generation menin inhibitor, KO-7246, into IND-enabling studies for potential applications in diabetes and cardiometabolic disease.
KURA has traded between $6.95 and $12.85 over the past year. Currently, KURA is trading at $12.27, up 8.78%.
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