Business
Kura Oncology Reports Fourth Quarter and Full Year 2024 Financial Results
– KOMET-001 registrational trial in R/R NPM1-mutant AML achieved primary endpoint – – Alignment reached with FDA and EMA on key aspects of the KOMET-017
About this update from Kura Oncology, Inc.
[{"type":"text","content":"– KOMET-001 registrational trial in R/R NPM1-mutant AML achieved primary endpoint – – Alignment reached with FDA and EMA on key aspects of the KOMET-017 protocol including use of MRD-negative CR endpoint for potential U.S. accelerated approval pathway in frontline intensive chemotherapy trial – – Topline MRD-negative CR results from KOMET-017-IC Phase 3 trial anticipated in 2028 – – Multiple data presentations for ziftomenib and pipeline programs expected throughout 2025 – – $727.4 million in cash, together with anticipated collaboration agreement payments, to support ziftomenib commercialization through the frontline AML combination setting – – Management to host webcast and conference call today at 4:30 p.m. ET – SAN DIEGO, Feb. 26, 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 fourth quarter and full year 2024 financial results and provided a corporate update. “We are very pleased the KOMET-001 registrational trial achieved its primary endpoint. We look forward to sharing topline data at an upcoming medical conference and expect to submit a New Drug Application (NDA) in relapsed/refractory (R/R) NPM1-mutant acute myeloid leukemia (AML) next quarter,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “In parallel, we are advancing ziftomenib into registrational studies in the frontline (1L) setting. Approximately half of patients with newly diagnosed NPM1-mutated (NPM1-m) AML and 80% of patients with KMT2A-rearranged (KMT2A-r) AML will die from the disease within five years. Given this unmet need, we are pleased to have reached alignment with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on key aspects of our Phase 3 trials, including the use of minimum residual disease (MRD)-negative complete response (CR) as a primary endpoint for potential accelerated approval in the U.S., with topline results anticipated in 2028. Our KOMET-017 trial is breaking new ground, and we and our partners at Kyowa Kirin are working as rapidly as possible to bring ziftomenib to AML patients worldwide.” Recent Highlights Positive topline results from registration-directed trial of ziftomenib in R/R NPM1-m AML – Kura and Kyo...