Kura Oncology reports positive trial results for AML treatment

SAN DIEGO - Kura Oncology, Inc. (NASDAQ:KURA), in partnership with Kyowa Kirin Co., Ltd. (TSE:4151), announced today at the American Society of Clinical Oncology (ASCO) Annual Meeting positive results from the Phase 2 KOMET-001 trial. The trial evaluated ziftomenib, an investigational oral menin inhibitor, for the treatment of relapsed or refractory (R/R) NPM1-mutant acute myeloid leukemia (AML). The clinical-stage biopharmaceutical company, currently valued at $540 million, maintains a strong financial position with more cash than debt on its balance sheet, according to InvestingPro data.

The study included 92 adult patients with an observed complete remission rate (CR) plus CR with partial hematological recovery (CRh) of 23% among the cohort. The median duration of CR/CRh responses was 3.7 months, with 63% of these patients achieving minimal residual disease (MRD)-negative status.

Safety data from 112 patients indicated a favorable profile with limited myelosuppression, and only 3% discontinued due to treatment-related adverse events. No significant QTc prolongation was reported, and differentiation syndrome events were manageable.

The companies are aiming for the first approval of ziftomenib, with a Prescription Drug User Fee Act (PDUFA) target action date set for November 30, 2025. The drug has received Breakthrough Therapy Designation from the FDA for R/R NPM1-m AML. While the stock has faced challenges, declining 72% over the past year, analysts remain optimistic, with five analysts recently revising their earnings estimates upward. InvestingPro analysis suggests the stock is currently undervalued, with additional insights available in the comprehensive Pro Research Report.

Dr. Troy Wilson, CEO of Kura Oncology, expressed optimism for the drug’s potential impact on patients with limited treatment options. Dr. Eunice Wang from Roswell Park Comprehensive Cancer Center highlighted the promising results, especially for heavily pretreated patients.

Kura Oncology will host a virtual investor event later today to discuss these findings further. The event will feature company management and trial investigators.

This news is based on a press release statement from Kura Oncology, Inc.

In other recent news, Kura Oncology reported a notable increase in revenue for the first quarter of 2025, reaching $14.1 million, up from zero in the same quarter last year. This revenue growth is attributed to strategic partnerships and advancements in their product pipeline, although earnings per share came in at -$0.66, slightly below the forecast of -$0.62. The company also announced that the FDA has accepted the New Drug Application for ziftomenib, a treatment for a specific subset of acute myeloid leukemia, with a target action date set for November 30, 2025. This submission was based on results from the Phase 2 KOMET-001 trial, which met its primary endpoint. Analysts at H.C. Wainwright reaffirmed their Buy rating for Kura Oncology, highlighting the significance of this regulatory milestone. Cantor Fitzgerald maintained an Overweight rating, noting the promising safety profile of ziftomenib compared to competitors. Kura Oncology continues to advance its pipeline, focusing on commercialization efforts and new trials, with a strong cash position expected to fund operations into 2027.

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