Kura Oncology’s new drug, ziftomenib, is still under FDA Priority Review for adults with R/R NPM1-m AML, with a target action date of November 30, 2025. Phase 3 trials for ziftomenib in frontline AML are progressing, with the drug being studied in settings covering over 50% of AML patients. Notable data on ziftomenib was presented at the 2025 ASH Annual Meeting, showcasing its potential in frontline and R/R NPM1-m AML. Additionally, clinical data at the ESMO 2025 Congress highlighted the promise of Kura’s strategic program with FTIs darlifarnib and tipifarnib in solid tumors. Kura has $609.7 million in cash to support its AML program until KOMET-017 results. Management will host a webcast and conference call at 8:00 a.m. ET.
Kura Oncology recently reported financial results for the third quarter of 2025, citing progress in the ziftomenib program and the broader precision oncology pipeline. Notable highlights included the initiation of pivotal KOMET-017 Phase 3 trials and the dosing of the first patient in the FLT3 inhibitor cohort of the KOMET-007 trial. Additionally, the Journal of Clinical Oncology published full results from the pivotal KOMET-001 trial evaluating ziftomenib in R/R NPM1-m AML. Abstracts featuring clinical data from ziftomenib in combination with venetoclax/azacitidine in AML patients were accepted for oral presentation at the ASH Annual Meeting. Preliminary clinical data presented at ESMO 2025 highlighted the potential of Kura’s FTIs darlifarnib and tipifarnib in various solid tumors. Kura received two $30 million milestone payments under its agreement with Kyowa Kirin for first patient dosing in the pivotal KOMET-017 trial.
Kura Oncology’s forecasted milestones include continued regulatory interactions with the FDA ahead of the PDUFA target action date for ziftomenib, presentation of clinical trial data at ASH Annual Meeting in December 2025, initiation of new expansion cohorts for darlifarnib and cabozantinib in RCC patients in early 2026, and preliminary data presentation for darlifarnib and adagrasib in KRASG12C-mutated solid tumor indications in 2026. Financially, Kura reported $20.8 million in collaboration revenue from Kyowa Kirin and net loss of $74.1 million for the third quarter of 2025. The company had $609.7 million in cash and believes it can fund operations into 2027.
Kura Oncology will host a webcast and conference call at 8:00 a.m. ET to discuss financial results and provide a corporate update. Additionally, a virtual analyst and investor event is planned for December 8, 2025, to discuss presentations from the ASH Annual Meeting. Kura is a company focused on precision medicines for cancer treatment, with a pipeline targeting cancer signaling pathways in hematologic malignancies and solid tumors. The company’s lead drug candidate, ziftomenib, aims to address the unmet needs in AML.
For additional information, please visit the Kura website at https://kuraoncology.com/. Contact Greg Mann at [email protected] for investor and media inquiries.
Read more at GlobeNewswire: Kura Oncology Reports Third Quarter 2025 Financial Results