Kura Oncology to present trial results for AML treatment

SAN DIEGO - Kura Oncology, Inc. (NASDAQ: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151), a pharmaceutical company with a market capitalization of $11.6 billion and strong revenue growth of 9% in the last twelve months, have announced the upcoming presentation of comprehensive data from the KOMET-001 trial at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, which will take place from May 30 to June 3, 2025, in Chicago, IL. According to InvestingPro analysis, Kyowa Kirin appears slightly undervalued at current levels.

The KOMET-001 trial is a pivotal study evaluating ziftomenib, a daily oral menin inhibitor, for the treatment of relapsed/refractory (R/R) NPM1-mutant (NPM1-m) acute myeloid leukemia (AML). The investigational therapy has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for this indication. With Kyowa Kirin’s robust EBITDA of $1.96 billion and P/E ratio of 29.4, the company appears well-positioned to support this development. Approximately 30% of AML cases involve NPM1 mutations, and currently, there are no FDA-approved therapies specifically targeting NPM1-m AML.

The trial met its primary endpoint of complete remission (CR) plus CR with partial hematological recovery (CRh), demonstrating statistical significance. Ziftomenib was reported to be well-tolerated with limited myelosuppression, and related discontinuations were low at 3%. Troy Wilson, Ph.D., J.D., President and CEO of Kura Oncology, expressed optimism about the drug’s safety, tolerability, and clinical efficacy.

The oral presentation of the trial results is scheduled for Monday, June 2, 2025, between 3:00 PM and 6:00 PM CDT, with the specific presentation time set from 4:36 PM to 4:48 PM CDT at McCormick Place, S100a. Additionally, a trial-in-progress abstract for the KOMET-015 trial will be presented in a poster session on May 31, 2025.

Following the ASCO meeting, Kura will host a virtual investor event on the same day at 7:30 pm ET to discuss the trial results, featuring management and investigators from the KOMET-001 study. Analysts maintain a cautiously optimistic outlook on Kyowa Kirin, with price targets ranging from $13.54 to $18.75. For deeper insights into analyst consensus and detailed financial metrics, consider subscribing to InvestingPro, which offers comprehensive analysis and real-time updates.

Kura Oncology is focused on the development of precision medicines for cancer treatment. Ziftomenib is part of their pipeline, and the company has submitted a New Drug Application for the therapy for R/R NPM1-m AML patients in the first quarter of 2025, in collaboration with Kyowa Kirin. The companies are also evaluating ziftomenib in combination with other treatments for newly diagnosed and R/R NPM1-m and KMT2A-rearranged AML. Kyowa Kirin maintains a FAIR financial health score according to InvestingPro’s comprehensive analysis, which evaluates multiple factors including profitability, cash flow, and growth metrics.

The information in this article is based on a press release statement from Kura Oncology, Inc.

In other recent news, Kura Oncology and Kyowa Kirin have submitted a New Drug Application to the U.S. Food and Drug Administration for ziftomenib, an investigational treatment targeting acute myeloid leukemia with a specific mutation. The application, submitted on March 31, 2025, focuses on adult patients with relapsed or refractory AML harboring a nucleophosmin 1 mutation. Ziftomenib has received Breakthrough Therapy, Fast Track, and Orphan Drug Designations from the FDA, which highlights its potential significance. The FDA’s 60-day review period will determine the application’s completeness, and Kura Oncology anticipates notification within the second quarter of 2025. A Priority Review has been requested, which could shorten the FDA review period to six months post-acceptance. The collaboration between Kura and Kyowa Kirin includes ongoing clinical trials to evaluate ziftomenib in combination with standard care for newly diagnosed and relapsed/refractory AML patients. This development aims to address the unmet need for targeted treatments in this patient population, pending FDA review and approval.

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