Syndax Pharmaceuticals, Inc. (SNDX) announced promising results on Tuesday from the cohort involving relapsed or refractory mutant NPM1 acute myeloid leukemia in the pivotal Phase 2 segment of the AUGMENT-101 clinical study for Revumenib.
This phase of the study included 64 adult participants with relapsed or refractory mNPM1 acute myeloid leukemia, with a median age of 65. The primary outcome measure was achieved, highlighting a combination of complete remission and partial hematological recovery rate of 23 percent among the evaluable adult patients.
Looking ahead, Syndax anticipates receiving FDA authorization for Revumenib, aimed at treating relapsed or refractory KMT2Ar acute leukemias, by the fourth quarter of 2024. Additionally, the company plans to file a supplemental New Drug Application (NDA) for addressing relapsed or refractory mNPM1 acute myeloid leukemia in the first half of 2025.
In pre-market trading, Syndax's shares are at $17.25, marking a decline of 20.57 percent on the Nasdaq.
