11:00 AM EDT, 07/29/2024 (MT Newswires) -- Syndax Pharmaceuticals ( SNDX ) said Monday the US Food and Drug Administration has extended the Prescription Drug User Fee Act, or PDUFA, action date for the new drug application for revumenib, providing the regulator more time to review additional data.

The filing of supplemental information to the regulator was considered a "major amendment" to the new drug application and led to a standard three-month extension to the original PDUFA action date of Sept. 26, Syndax said.

The regulator has not requested additional trials or manufacturing information, the company added.

Syndax is seeking approval of revuminib as a treatment for relapsed or refractory KMT2Ar acute leukemia.

The company's shares were falling 12% in recent trading.

Price: 21.54, Change: -2.95, Percent Change: -12.05