Kura Oncology, Kyowa Kirin announce submission of NDA for ziftomenib to FDA

Kura Oncology (KURA) announced Kura submitted a New Drug Application for ziftomenib, a highly selective, once-daily, oral, investigational menin inhibitor, for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with a nucleophosmin 1 mutation to the U.S. Food and Drug Administration on March 31, 2025. “This NDA submission brings us one step closer to our goal of advancing ziftomenib to market as a new therapeutic option for adult patients with R/R NPM1-m AML, a devastating disease for which there are currently no FDA-approved targeted therapy options,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “We look forward to working closely with the FDA throughout the review process and are optimistic about the potential of ziftomenib to impact patients with NPM1-mutant AML. We extend our gratitude to the team at Kura, our dedicated investigators, study site teams, and most importantly, to the patients who participated in our clinical trials, and their families and caregivers, who all helped make this possible. We appreciate the support and cooperation we enjoy with our partner Kyowa Kirin, and we look forward with confidence to the continued progress of this program and our collaboration.”