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American Focus > Blog > Economy > Syndax’s Revumenib Added to NCCN AML Guidelines Ahead of October 25 FDA Decision
Economy

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

Last updated: October 6, 2025 2:53 pm
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Syndax’s Revumenib Added to NCCN AML Guidelines Ahead of October 25 FDA Decision
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Syndax Pharmaceuticals Inc. (NASDAQ:SNDX) has emerged as a leading contender among the top stocks priced under $20. On September 19, the company reached a significant achievement: the National Comprehensive Cancer Network (NCCN) revised its Clinical Practice Guidelines in Oncology to include Revuforj (revumenib) for acute myeloid leukemia (AML).

Revumenib has received a Category 2A recommendation to treat relapsed or refractory (R/R) AML featuring an NPM1 mutation/mNPM1. This recommendation follows promising results from the AUGMENT-101 clinical trial, which were published in the journal Blood in 2025. Previously, revumenib was also listed as a Category 2A treatment option for R/R acute leukemia with a KMT2A rearrangement in the NCCN Guidelines for AML and acute lymphoblastic leukemia (ALL).

Syndax's Revumenib Included in NCCN AML Guidelines Before October 25 FDA Decision

Syndax’s Revumenib Included in NCCN AML Guidelines Before October 25 FDA Decision

Syndax has filed a supplemental New Drug Application (sNDA) seeking approval for revumenib in treating R/R mNPM1 AML. The US FDA has designated the sNDA for Priority Review and is evaluating it through the Real-Time Oncology Review (RTOR) program, aiming for a Prescription Drug User Fee Act (PDUFA) target action date on October 25 this year.

Syndax Pharmaceuticals Inc. (NASDAQ:SNDX) operates as a commercial-stage biopharmaceutical firm focusing on cancer therapies.

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See also  Maltese ‘golden’ passports were sold to Russians with Ukraine war links

Disclosure: None. This article originally appears on Insider Monkey.

TAGGED:AddedaheadAMLdecisionFDAguidelinesNCCNOctoberRevumenibSyndaxs
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