Enliven Therapeutics reported that, as of December 22, 2025, 60 patients with relapsed, refractory or TKI-intolerant chronic myeloid leukemia were enrolled in its Phase 1b ENABLE trial of ELVN-001. In the initial 80 mg once-daily cohort (n=19), 47 percent of evaluable patients achieved a cumulative major molecular response (MMR) by 24 weeks, with 16 percent reaching deep molecular response (DMR). In the randomized 60 mg and 120 mg arms (n=41), a 69 percent cumulative MMR rate was observed, including a 35 percent DMR rate. Across all cohorts, every patient in MMR at enrollment maintained or deepened their response by 24 weeks.

ELVN-001 demonstrated a consistent safety profile with no maximum tolerated dose identified. Adverse events were largely low grade and comparable to those seen in earlier ELVN-001 studies. There were no new safety signals reported in the 80 mg, 60 mg or 120 mg once-daily cohorts, supporting further dose selection discussions with regulators and enabling expansion into later-stage trials without dose-limiting toxicities.

Enliven plans to present additional Phase 1 ENABLE data at a mid-year scientific meeting, followed by formal dose-selection discussions with the U.S. Food and Drug Administration. The company aims to initiate its global Phase 3 ENABLE-2 trial in the second half of 2026. These milestones will shape the pivotal development path, with potential registrational endpoints including MMR and DMR by 24 weeks and safety measures in heavily pretreated CML populations.

On the Thursday following the data release, ELVN stock traded with a session volume of 6.61 million shares, more than ten times its three-month average daily volume of 631,520 shares, according to Benzinga Pro. The surge in trading activity reflects renewed investor confidence in ELVN-001’s potential to address unmet needs in chronic myeloid leukemia and positions Enliven for heightened market visibility as it advances toward Phase 3 initiation.