Enliven reports 61% MMR in Phase 1b CML trial; FDA aligns on Phase 3 design

Enliven Therapeutics announced updated positive Phase 1 data for ELVN-001 in chronic myeloid leukemia with 61% overall response rates and FDA alignment on the 80 mg dose for the pivotal Phase 3 ENABLE-2 trial. The company expects to initiate the Phase 3 study in the second half of 2026, representing a key regulatory milestone for this potential best-in-class therapy.