Enliven Therapeutics reaches FDA alignment on Phase 3 trial design for relcobatinib in CML

Enliven Therapeutics (ELVN) announced FDA alignment on the final design of the ENABLE-2 Phase 3 trial for relcobatinib in previously treated CML. The ~450-patient randomized trial compares relcobatinib to second-generation TKIs with MMR at Week 24 as primary endpoint. Company on track to initiate before year-end 2026.