– 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 supplemen ...

– Primary endpoint met in R/R mNPM1 AML patients in pivotal Phase 2 portion of the AUGMENT-101 trial – – Robust remission rates in heavily pre-treated R/R mNPM1 AML population with nearly 50% overall response rate – – sNDA for revumenib in R/R mNPM1 AML submitted in April 2025 – NEW YORK, May 07, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced that data from the pivotal Phase 2 portion of the ...