Kura Oncology and Syndax Pharmaceuticals in Tight Race for AML Drug Approval

FDA Grants Priority Review to Competing Menin Inhibitors

Kura Oncology and Syndax Pharmaceuticals are locked in a head-to-head race for FDA approval of their respective acute myeloid leukemia (AML) drugs. Both companies have received priority review status for their oral menin inhibitors, setting the stage for a potentially groundbreaking advancement in AML treatment.

Kura Oncology announced on Sunday that the FDA has accepted its New Drug Application (NDA) for ziftomenib, granting it priority review with a PDUFA date of November 30. This news comes just two months after Syndax's submission for Revuforj, which has a PDUFA date of September 26. Both drugs target adult patients with relapsed or refractory AML harboring specific mutations.

Promising Phase II Data Bolsters Kura's Position

At the American Society of Clinical Oncology (ASCO) 2025 conference, Kura Oncology presented encouraging Phase II data for ziftomenib. In a study of 92 heavily pretreated patients with NPM1-mutant AML, 21 achieved complete remission or complete remission with partial hematologic recovery, resulting in a response rate of 23%.

Mizuho analysts noted that these results were "in line with expectations" and consistent with previously released information. The data presentation at ASCO 2025 coincided with the FDA's acceptance of Kura's NDA, causing the company's stock to surge by approximately 17% in early Monday trading.

Strategic Partnerships and Market Implications

The race between Kura Oncology and Syndax Pharmaceuticals extends beyond regulatory milestones. In November of the previous year, Syndax's Revuforj became the first FDA-approved menin inhibitor for a different type of leukemia. Shortly after, Kura Oncology secured a significant co-development and commercialization deal with Kyowa Kirin for ziftomenib.

Under the terms of this agreement, Kyowa Kirin provided Kura with an upfront payment of $330 million and committed to potential milestone payments totaling up to $1.16 billion. The partnership grants Kyowa Kirin commercialization rights for ziftomenib outside the United States, with Kura eligible for royalties on sales.

As the pharmaceutical industry closely watches this unfolding competition, the outcome of these regulatory decisions could significantly impact the treatment landscape for AML patients with specific mutational profiles. The approval of either drug would mark a milestone as the first targeted therapy for this particular AML subtype, potentially offering new hope to patients with limited treatment options.