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Syndax Announces Positive Pivotal Topline Results from Relapsed or Refractory mNPM1 AML Cohort in AUGMENT-101 Trial of Revumenib
Syndax Pharmaceuticals (SNDX)announced positive topline results from the AUGMENT-101 trial of revumenib in relapsed/refractory mNPM1 AML patients. The trial met its primary endpoint with a 23% complete remission rate (p-value = 0.0014) and achieved a 47% overall response rate in a heavily pre-treated population. The safety profile was favorable, with only 5% of patients discontinuing due to treatment-related adverse events. The company plans to submit a supplemental New Drug Application (sNDA) in the first half of 2025, following anticipated FDA approval for KMT2Ar acute leukemia in Q4 2024.
Syndax Pharmaceuticals (SNDX)announced positive topline results from the AUGMENT-101 trial of revumenib in relapsed/refractory mNPM1 AML patients. The trial met its primary endpoint with a 23% complete remission rate (p-value = 0.0014) and achieved a 47% overall response rate in a heavily pre-treated population. The safety profile was favorable, with only 5% of patients discontinuing due to treatment-related adverse events. The company plans to submit a supplemental New Drug Application (sNDA) in the first half of 2025, following anticipated FDA approval for KMT2Ar acute leukemia in Q4 2024.
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