Early clearance of measurable residual disease (MRD) after induction therapy in patients with acute myeloid leukemia (AML) is associated with significantly better relapse-free survival (RFS ...

The company’s KOMET-001 pivotal Phase 2 trial in relapsed/refractory NPM1-mutated AML has met its primary endpoint ... and minimal residual disease (MRD) negativity without significant adverse events ...

The company’s KOMET-001 pivotal Phase 2 trial in relapsed/refractory NPM1-mutated AML has met its ... and minimal residual disease (MRD) negativity without significant adverse events like ...

Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) Q4 2024 Earnings Call Transcript March 3, 2025 Operator: Good day, everyone, and welcome to the Syndax Fourth Quarter and Full Year 2024 Earnings ...

Patients with undetectable MRD at landmark and longitudinal time points had significantly longer disease-free survival than patients who had detectable MRD at those time points. Prolonged ...

Also in the second quarter, we expect to publish the pivotal NPM1 data and believe this could ... the overall response rate was 100% and the MRD negative rate was 95% among 37 efficacy evaluable ...

The U.S. FDA also granted Fast Track designation to revumenib for the treatment of adult and pediatric patients with R/R acute leukemias harboring a KMT2A rearrangement or NPM1 mutation and ...

Alignment reached with FDA and EMA on key aspects of the KOMET-017 protocol including use of MRD-negative CR endpoint ... Submit an NDA for ziftomenib in R/R NPM1-m AML in the second quarter ...

We're preparing to commercialize ziftomenib as a potentially best-in-class menin inhibitor for patients with relapsed and/or refractory NPM1-mutant ... the trials to use MRD-negative CR and ...

The trial will assess MRD-negative complete response and event ... For ziftomenib, we expect to submit an NDA in relapsed/refractory NPM1-mutant AML in Q2, present top-line data for KOMET-001 ...

Alignment reached with FDA and EMA on key aspects of the KOMET-017 protocol including use of MRD-negative CR endpoint for potential ... Submit an NDA for ziftomenib in R/R NPM1-m AML in the second ...