Syndax Announces PDUFA Action Date Extension for Revumenib NDA for Relapsed or Refractory KMT2Ar Acute Leukemia

July 29, 2024

https://www.prnewswire.com/news-releases/syndax-announces-pdufa-action-date-extension-for-revumenib-nda-for-relapsed-or-refractory-kmt2ar-acute-leukemia-302208308.html

– New PDUFA action date of December 26, 2024 allows FDA additional time to complete their review – 

WALTHAM, Mass., July 29, 2024 /PRNewswire/ — Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for revumenib for the treatment of adults and pediatric patients with relapsed or refractory (R/R) KMT2Ar acute leukemia. 

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