Kura Oncology won FDA priority review for its drug the day before announcing new data at ASCO 2025 showing remission in about one-quarter of patients. But Syndax’s Revuforj also has priority review in this indication, with a PDUFA date two months earlier.
Kura Oncology showed off new Phase II data for its acute myeloid leukemia drug and, at about the same time, got its New Drug Application accepted at the FDA with a PDUFA date set for late this year. That puts Kura in a head-to-head race with Syndax, which submitted an NDA to the agency in April in the same AML subtype for its drug Revuforj, which last fall earned approval for a different type of leukemia.
On Sunday, the San Diego–based Kura and its development partner Kyowa Kirin announced that their NDA for ziftomenib, for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with specific mutations, had been accepted by the FDA with priority review.
The PDUFA date is set for Nov. 30—just over two months after Syndax’s Sept. 26 PDUFA. Revuforj has also been granted priority review. Whichever drug gets approved first would be the first for patients with AML with this specific mutational background.
Kura’s stock jumped about 17% early Monday after the news of the NDA acceptance.
Later that day at ASCO 2025, the company showcased the data behind that acceptance. In 92 patients who had been pretreated for R/R NPM1-mutant AML, 21 achieved full remission or remission with some blood cell recovery, good for a complete remission or complete remission with partial hematologic recovery rate of 23%.
“Overall, results were in line with expectations,” Mizuho analysts wrote in a note to investors early Tuesday, adding that the presented results lined up with previously released info in the conference’s abstract.
Both ziftomenib and Syndax’s Revuforj are oral menin inhibitors, a new class of anti-cancer drugs. Revuforj’s approval for leukemia last November represented the first FDA nod for the class. A week after Revuforj’s FDA approval, Kura signed a co-development and commercialization deal for ziftomenib with Kyowa Kirin, wherein the latter paid Kura $330 million upfront and pledged up to $1.16 billion total in milestone payments. That deal gave Kyowa Kirin commercialization rights for the drug outside the U.S., with potential royalties due to Kura.
