Syndax’s Revuforj Granted FDA Priority Review for Relapsed/Refractory Mutant NPM1 AML

Syndax Pharmaceuticals Inc. (NASDAQ:SNDX) is one of the most promising stocks according to Wall Street analysts. On June 24, Syndax announced that the US FDA granted Priority Review for its supplemental New Drug Application (sNDA) for Revuforj (revumenib). The sNDA seeks approval for the treatment of relapsed or refractory (R/R) mutant NPM1 (mNPM1) acute myeloid leukemia/AML.

The FDA is reviewing the sNDA under its Real-Time Oncology Review/RTOR program, which facilitates an efficient review process with close engagement between the sponsor and the FDA. The Prescription Drug User Fee Act/PDUFA target action date for this sNDA is set for October 25 this year. Revuforj is an oral, first-in-class menin inhibitor that received initial FDA approval in 2024 for the treatment of R/R acute leukemia with a KMT2A translocation in adult and pediatric patients aged one year and older.

Syndax's Revuforj Granted FDA Priority Review for Relapsed/Refractory Mutant NPM1 AML

A scientist in a laboratory testing a monoclonal antibody for the treatment of cancer.

If approved, this sNDA would expand Revuforj’s indication to include patients with R/R AML who have an NPM1 mutation. Mutations in the NPM1 gene are the most common genetic alteration observed in adults with AML, occurring in ~30% of cases. These mutations are crucial in the development of mNPM1 AML, which is an aggressive blood cancer. Currently, there are no approved therapies that specifically target the underlying disease mechanisms driving mNPM1 AM.

Syndax Pharmaceuticals Inc. (NASDAQ:SNDX) is a commercial-stage biopharmaceutical company that develops therapies for the treatment of cancer.

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Disclosure: None. This article is originally published at Insider Monkey.