Business
Kura Oncology Reports Third Quarter 2025 Financial Results
– New Drug Application for ziftomenib in adults with R/R NPM1-m AML remains under FDA Priority Review, with a PDUFA target action date of November 30, 2025 –
About this update from Kura Oncology, Inc.
[{"type":"text","content":"– New Drug Application for ziftomenib in adults with R/R NPM1-m AML remains under FDA Priority Review, with a PDUFA target action date of November 30, 2025 – – KOMET 017 Phase 3 trials to evaluate ziftomenib in combination with intensive and non-intensive chemotherapy in frontline AML are accelerating; ziftomenib being investigated in settings representing more than 50% of AML patients – – Two oral presentations at 2025 ASH Annual Meeting on ziftomenib in combination with venetoclax / azacitidine chemotherapy in frontline and R/R NPM1-m AML – – Clinical data at ESMO 2025 Congress highlight promise of second strategic program – FTIs darlifarnib and tipifarnib show promising safety profile and clinical activity with targeted therapies in solid tumors – – $609.7 million in pro forma cash, together with anticipated collaboration payments, expected to support ziftomenib AML program through topline results in KOMET-017 – – Management to host webcast and conference call today at 8:00 a.m. ET – SAN DIEGO, Nov. 04, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported third quarter 2025 financial results and provided a corporate update. “Our momentum is accelerating across the ziftomenib program and our broader precision oncology pipeline,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer. “With the initiation of the pivotal KOMET-017 Phase 3 trials, we are executing a robust, focused development strategy to unlock ziftomenib’s best-in-class potential across the continuum of unmet need in AML. Bolstered by a strong balance sheet and our productive partnership with Kyowa Kirin, we are well positioned to advance ziftomenib toward commercialization, accelerate our frontline Phase 3 trials and create enduring value across our pipeline for patients and other key stakeholders.” Recent Highlights In September 2025, we announced the first patient was dosed in the Phase 3 KOMET-017 trial of ziftomenib in frontline AML (NCT07007312). KOMET-017 comprises two global, randomized, double-blind, placebo-controlled trials to evaluate ziftomenib in combination with both intensive and non-intensive chemotherapy regimens in patients with newly diagnosed NPM1-m or KMT2A-rearranged (KMT2A-...