Shares of Enliven Therapeutics Inc. (ELVN) are up over 50% today, following the announcement of positive initial data from the ongoing Phase 1b ENABLE trial.
ENABLE is a phase 1 trial evaluating the company's investigational drug ELVN-001 in patients with chronic myeloid leukemia that is relapsed, refractory or intolerant to available tyrosine kinase inhibitors.
In the phase 1b ENABLE trial, patients were first enrolled in the 80 mg once daily (QD) cohort and subsequent patients were randomised to either 60 mg QD or 120 mg QD.
As of the cutoff date of December 22, 2025, 60 patients had been enrolled in the initial cohorts of the Phase 1b trial, with 19 in the 80mg cohort and 41 in the combined 60mg and 120mg cohorts.
In the 80mg cohort, the rates of major molecular response (MMR, 38%) and deep molecular response (DMR, 16%) compare favourably with prior Phase 1 trials of approved BCR::ABL1 TKIs, including Novartis' Asciminib (Scemblix), noted the company.
In the 60mg and 120mg cohorts, highly encouraging rates were observed, with MMR of 53% and DMR of 35%. The cumulative MMR rates are 47% in the 80mg cohort and 69% in the combined 60mg/120mg cohorts.
The company expects to present additional Phase 1 ENABLE trial data in mid-year and to initiate ENABLE-2, the Phase 3 trial of ELVN-001, in the second half of 2026.
When we alerted readers to ELVN on November 10, 2025, it was trading at $17.82. As of this writing, the stock is at $23.48, up 51%.
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