Stocks and data
Enliven Therapeutics Inc (NASDAQ:ELVN) experienced a 23% jump in premarket trading on Thursday following the release of updated Phase 1 results for ELVN-001, the company's investigational therapy for chronic myeloid leukemia (CML). The clinical-stage biopharmaceutical firm disclosed detailed outcomes from its ENABLE study, which evaluated ELVN-001 in patients who had received prior treatment.
Key efficacy findings
The company reported that, within the 80 mg once-daily Phase 1b cohort, 61% of patients achieved an overall major molecular response (MMR). In that same cohort, 48% of patients reached MMR by 24 weeks. Across the broader Phase 1b population, patients with one or two prior unique tyrosine kinase inhibitors (TKIs) recorded a 67% overall MMR and a 55% MMR rate by 24 weeks.
Trial population and exposure
The ENABLE trial enrolled 161 patients across dose levels from 10 mg to 240 mg daily. The median duration of treatment in the study was 35 weeks, and as of the data cutoff on March 10, 2026, 76% of participants remained on study. The company also reported that 62% of enrolled patients had previously received asciminib.
Safety profile
- Discontinuations due to adverse events occurred in 6% of patients.
- Grade 3 or higher treatment-emergent adverse events were observed in 34% of participants overall.
- The most common Grade 3+ events, each occurring in 6% of patients, were thrombocytopenia, neutropenia and lipase elevation.
Regulatory pathway and next steps
Enliven said it has reached alignment with the U.S. Food and Drug Administration on selecting 80 mg once daily as the recommended dose for Phase 3 development and on the patient population to be included in the ENABLE-2 pivotal trial. The company expects to start the ENABLE-2 trial in the second half of this year, targeting patients with CML who have been treated previously with one or more TKIs.
Mechanism
ENLVN-001 is designed to target the BCR::ABL1 gene fusion, the oncogenic driver in patients with CML.
What this means for markets
The stock reaction reflects investor response to both efficacy and tolerability data and to regulatory agreement on a Phase 3 dose and population. Clinical progress in a targeted oncology program can affect valuation and clinical readouts in the biotech sector broadly, and may influence capital allocation decisions among specialized biopharma investors.
Brief summary
Updated Phase 1 ENABLE data for ELVN-001 demonstrated notable MMR rates in the 80 mg Phase 1b cohort and across patients previously treated with one or two TKIs. The safety profile showed a relatively low discontinuation rate and identified thrombocytopenia, neutropenia and lipase elevation as the most common Grade 3+ events. Enliven and the FDA agreed on an 80 mg once-daily Phase 3 dose and the patient population for ENABLE-2, which the company plans to initiate in the second half of this year.