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– PDUFA action date set for October 25, 2025 –
– sNDA being reviewed under FDA's RTOR program –
– Revumenib has the potential to become the first and only menin inhibitor approved in both R/R mNPM1 AML and R/R KMT2Ar acute leukemia –
NEW YORK, June 24, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (NASDAQ:SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its supplemental New Drug Application (sNDA) for Revuforj® (revumenib) for the treatment of relapsed or refractory (R/R) mutant NPM1 (mNPM1) acute myeloid leukemia (AML). The sNDA is being reviewed under the FDA's Real-Time Oncology Review (RTOR) program and has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 25, 2025. RTOR allows for a more efficient review and close engagement between the sponsor and the FDA throughout the submission process.
Posted In: SNDX
