Syndax Says Revumenib NDA Granted FDA Priority Review
By Stephen Nakrosis
Syndax Pharmaceuticals on Tuesday said the U.S. Food and Drug Administration granted a priority review to the new drug application for revumenib as a treatment for certain leukemia patients.
The NDA filing is being reviewed under the FDA's real-time oncology review program, Syndax said. The company added the review has been given a Prescription Drug User Fee Act target action date of Sept. 26.
Syndax said the review is being supported by positive data from the AUGMENT-101 trial of revumenib in adult and pediatric patients with KMT2Ar acute myeloid leukemia and acute lymphoid leukemia. The company previously reported that the trial met its primary endpoint.
Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
March 26, 2024 16:48 ET (20:48 GMT)
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