The approval, based on results from the Phase 3 AMPLIFY trial, marks the first all-oral, fixed-duration regimen for first-line CLL therapy
The trial aims to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the combination therapy
Enzomenib, an oral, small-molecule inhibitor designed to disrupt the menin-MLL protein interaction involved in leukemogenesis
The submission is supported by positive results from the Phase 3 AMPLIFY trial
Clinical data showing unprecedented remission rates in newly diagnosed AML patients support advancing ICT01 into pivotal trials
AMPLIFY Phase III trial results demonstrated statistically significant and clinically meaningful improvement in progression-free survival for Calquence combinations
Projected ~US$100 million cash balance of combined company expected to fund operations through mid-2025 and to clinical data over the next 12 to 24 months
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