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Investing.com -- Syndax Pharmaceuticals Inc (NASDAQ:SNDX) stock gained 2.5% after the FDA granted Priority Review for its supplemental New Drug Application (sNDA) for Revuforj, potentially expanding the drug’s use to treat relapsed or refractory mutant NPM1 acute myeloid leukemia.
The FDA assigned a PDUFA target action date of October 25, 2025, for the application, which is being reviewed under the FDA’s Real-Time Oncology Review program. This program allows for more efficient review and closer engagement between Syndax and regulators throughout the submission process.
Revuforj, an oral menin inhibitor, received initial FDA approval in 2024 for treating relapsed or refractory acute leukemia with a KMT2A translocation in adult and pediatric patients one year and older. If approved, this expansion would include patients with NPM1 mutations, which represent the most common genetic alteration in acute myeloid leukemia.
"We are pleased that the FDA has granted Priority Review to our sNDA in R/R mNPM1 AML, a filing which builds on the initial approval of Revuforj for R/R acute leukemia with a KMT2A translocation in 2024," said Michael A. Metzger, Chief Executive Officer of Syndax.
The sNDA submission is supported by positive pivotal data from the AUGMENT-101 trial. Results from this study were published in the journal Blood in May 2025 and presented at the European Hematology Association Annual Congress Meeting in June 2025.
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