Syndax Pharmaceuticals Announces FDA Approval of Revuforj for R/R Acute Leukemia with KMT2A Translocation and Submits Supplemental NDA for R/R mNPM1 AML

Reuters
06-12
Syndax Pharmaceuticals Announces FDA Approval of Revuforj for R/R Acute Leukemia with KMT2A Translocation and Submits Supplemental NDA for R/R mNPM1 AML

NEW YORK, June 12, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals, a commercial-stage biopharmaceutical company, announced new data from the AUGMENT-101 trial of their menin inhibitor, Revuforj® (revumenib), during the 30th European Hematology Association Annual Congress. These findings have led to the FDA approval of Revuforj for patients with relapsed or refractory acute leukemia featuring a KMT2A translocation. Additionally, these results underpin a supplemental New Drug Application (NDA) submitted to the FDA for treating relapsed or refractory mutant NPM1 acute myeloid leukemia $(AML.AU)$, addressing a significant unmet medical need.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Syndax Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9467468-en) on June 12, 2025, and is solely responsible for the information contained therein.

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