Kura Oncology Secures $30M Payment Advancing Key Leukemia Drug
Milestone from partner Kyowa Kirin triggered by start of pivotal Phase 3 trial for ziftomenib in frontline acute myeloid leukemia, bolstering the company's finances.
Kura Oncology Inc. (NASDAQ: KURA) has received a $30 million milestone payment from its partner Kyowa Kirin, providing a significant non-dilutive capital infusion as the company advances its lead cancer drug, ziftomenib, into a crucial late-stage trial for acute myeloid leukemia (AML).
The payment was triggered by the dosing of the first patient in the KOMET-017 Phase 3 registrational trial, a study targeting newly diagnosed patients with specific genetic mutations. Shares of the San Diego-based biopharmaceutical company traded actively on the news, as the milestone strengthens Kura’s balance sheet and marks critical progress in developing a potential new frontline therapy for a hard-to-treat blood cancer.
Ziftomenib is an investigational, once-daily oral drug known as a menin inhibitor, which targets the underlying drivers of genetically defined subsets of AML, specifically those with NPM1 mutations or KMT2A rearrangements. The KOMET-017 study, which began on September 29, is a global, randomized, placebo-controlled trial evaluating the drug in combination with both intensive and non-intensive chemotherapy. This dual-pronged approach aims to secure a broad label for ziftomenib as a frontline treatment option.
For a clinical-stage company like Kura, the $30 million payment provides more than just capital; it offers validation of the ziftomenib program and extends its financial runway without diluting shareholder equity. As of its last quarterly report on June 30, 2025, the company held a strong cash position of $630.7 million. This latest infusion is expected to help fund operations into 2027, a critical period as it pushes its lead drug toward commercialization.
Investors and analysts are closely watching Kura as it approaches another major catalyst. The U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2025, for a separate application for ziftomenib. That decision is for its use as a monotherapy in patients with relapsed or refractory NPM1-mutant AML, based on positive data from the KOMET-001 trial. An approval in that setting would mark Kura's transition from a development-stage to a commercial-stage company.
Wall Street remains broadly optimistic about the company's prospects. Kura Oncology currently holds a consensus "Buy" rating from 15 covering analysts, with an average price target of $27.00 per share, suggesting significant upside from its current trading level of around $9.10. The company has a market capitalization of approximately $805 million.
The AML treatment landscape is a competitive and rapidly evolving field, with a market projected to grow to over $9.6 billion by 2034. Kura’s ziftomenib is positioned against other targeted therapies, including Syndax Pharmaceuticals' revumenib, which also targets a similar patient population. However, Kura's strategy of pursuing a frontline indication in its Phase 3 trial could open up a substantially larger market opportunity compared to treatments focused solely on relapsed patients.
By securing the milestone payment, Kura Oncology has reinforced its financial stability and taken a tangible step forward in its quest to bring a novel, targeted therapy to AML patients. All eyes will now turn to the FDA's upcoming decision in November, an event that could prove transformative for the company and its shareholders.