ELVN Stock Rallies 51% Following Encouraging Phase 1b Results In Refractory Leukemia

Enliven Therapeutics Inc. (ELVN) experienced significant share appreciation today, climbing over 51% after unveiling compelling clinical data from its ongoing Phase 1b ENABLE trial. The surge reflects positive market reception to the interim efficacy results of ELVN-001, the company’s experimental therapeutic candidate targeting patients with chronic myeloid leukaemia who have developed resistance or intolerance to standard tyrosine kinase inhibitor treatments.

Trial Design And Patient Enrollment

The Phase 1b ENABLE study encompasses a multi-dose evaluation framework. Initial cohorts enrolled patients at an 80 mg once-daily dosing regimen, with subsequent participants randomized to either 60 mg or 120 mg daily dosing schedules. As of the December 22, 2025 data cutoff, the trial had enrolled a cumulative 60 patients across these initial cohorts—19 in the lower-dose arm and 41 distributed between the mid-range and higher-dose cohorts.

Efficacy Benchmarks Exceed Expectations

The efficacy metrics disclosed demonstrate promising therapeutic potential across both dosing evaluations. The lower 80 mg cohort achieved a major molecular response (MMR) rate of 38% and deep molecular response (DMR) rate of 16%, performance characteristics that compare favorably against historical Phase 1 trial outcomes documented for previously approved BCR-ABL1 tyrosine kinase inhibitors.

The intermediate and higher-dose cohorts (60 mg and 120 mg combined) delivered substantially more encouraging results. These patient populations demonstrated an MMR rate of 53% and DMR achievement of 35%—substantially higher efficacy indicators. When cumulative response data are evaluated across all dosing arms, the 80 mg cohort shows 47% cumulative MMR, while the combined 60/120 mg cohorts demonstrate 69% cumulative MMR rates.

Timeline And Next Steps

Enliven has communicated its intent to present expanded Phase 1 ENABLE trial findings mid-year 2026. The company simultaneously plans to initiate ENABLE-2, its Phase 3 pivotal trial evaluating ELVN-001, during the second half of 2026.

Market Performance

The stock had been trading at $17.82 when the position was initially flagged in early November 2025. At current levels of $23.48, shares have appreciated approximately 51%, reflecting investor optimism regarding the chronic myeloid leukaemia treatment candidate’s clinical progress and commercial potential.