01:51 PM EDT, 10/24/2025 (MT Newswires) -- Syndax's (SNDX) revumenib was approved by the US Food and Drug Administration as a treatment for relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation, the regulator said Friday.

The drug was approved for use in adults and children at least one year old who have no satisfactory alternative treatment options, according to the FDA.

The approval was based on a multicenter trial by Syndax, which showed a complete remission and complete remission with partial blood count recovery rate of 23.1%, the FDA said.

Trading of Syndax shares were halted after midday Friday.

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