Clinical TrialsManagement is highly confident in NATiV3 reaching the target of randomizing 969 patients into the main cohort, paving the way for the trial's top-line data readout.
Regulatory ApprovalLanifibranor could become the second orally-dosed MASH therapy approved by the FDA, exhibiting a stronger efficacy profile compared to resmetirom.
Safety And EfficacyLanifibranor's safety in the NATiV3 trial has recently been confirmed by the trial's Data Monitoring Committee, recommending NATiV3 to continue with no modifications to the protocol.