Syndax's Revumenib Added to NCCN AML Guidelines Ahead of October 25 FDA Decision

Syndax Pharmaceuticals Inc. (NASDAQ:SNDX) is one of the best stocks to buy under $20. On September 19, Syndax Pharmaceuticals announced a major milestone: the National Comprehensive Cancer Network/NCCN updated its Clinical Practice Guidelines in Oncology/NCCN Guidelines for Acute Myeloid Leukemia/AML to include Revuforj (revumenib).

Revumenib received a Category 2A recommendation for the treatment of relapsed or refractory (R/R) AML with an NPM1 mutation/mNPM1. This update was based on positive pivotal results from the AUGMENT-101 trial of revumenib, which were published in the journal Blood in 2025. The NCCN Guidelines for AML and acute lymphoblastic leukemia/ALL already included revumenib as a Category 2A recommendation for R/R acute leukemia with a KMT2A rearrangement.

Syndax has submitted a supplemental New Drug Application/sNDA seeking approval for revumenib to treat R/R mNPM1 AML. The US FDA granted the sNDA Priority Review and is reviewing it under the Real-Time Oncology Review/RTOR program, setting a Prescription Drug User Fee Act/PDUFA target action date of October 25 this year.

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.