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Syndax announces updated NCCN Guidelines for AML

Syndax (SNDX) Pharmaceuticals announced that the National Comprehensive Cancer Network, NCCN, Clinical Practice Guidelines in Oncology for Acute Myeloid Leukemia, AML, were updated to include revumenib as a category 2A recommendation for relapsed or refractory acute myeloid leukemia with an NPM1 mutation. The update was based on positive pivotal results from the AUGMENT-101 trial of revumenib which were published in the journal Blood in 2025.2 The NCCN Guidelines for AML and acute lymphoblastic leukemia, ALL, continue to also include revumenib as a category 2A recommendation for R/R acute leukemia with a KMT2A rearrangement. The Company has submitted a supplemental New Drug Application seeking the approval of revumenib for the treatment of R/R mNPM1 AML. The sNDA has been granted Priority Review by the FDA and assigned a Prescription Drug User Fee Act target action date of October 25, 2025.

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