Syndax (SNDX) announced that the FDA has granted priority review for its supplemental new drug application for Revuforj for the treatment of relapsed or refractory mutant NPM1 acute myeloid leukemia. The sNDA is being reviewed under the FDA’s Real-Time Oncology Review program and has been assigned a Prescription Drug User Fee Act target action date of October 25. RTOR allows for a more efficient review and close engagement between the sponsor and the FDA throughout the submission process.
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