Shares of Enliven Therapeutics Inc. (NASDAQ: ELVN) surged prominently on Thursday trading, reflecting heightened investor interest fueled by encouraging clinical trial data. The stock recorded a trading volume of approximately 6.61 million shares, a substantial rise against its typical daily average volume of 631,520 shares, according to market analytics from Benzinga Pro.
The company, positioned within the clinical-stage biopharmaceutical sector, unveiled initial results from its ongoing Phase 1b ENABLE trial evaluating ELVN-001. This investigational compound targets patients with chronic myeloid leukemia (CML) who have either relapsed, are refractory, or intolerant to existing tyrosine kinase inhibitors (TKIs), a common drug class for managing CML.
Per trial data collected through the assessment cutoff of December 22, 2025, a total of 60 patients, all heavily pre-treated prior to enrollment, were included in the study parameters. The Phase 1b study design incorporated distinct dosing cohorts, notably the 80 mg once-daily (QD) group featuring 19 patients. In this cohort, all participants were evaluable for efficacy endpoints at the 24-week mark.
The 80 mg cohort demonstrated competitive efficacy profiles, registering a 38% major molecular response (MMR) rate and a 16% deep molecular response (DMR) rate. These figures are particularly notable when compared with outcomes from prior Phase 1 clinical trials involving approved BCR::ABL1-targeting TKIs, such as Novartis AG's (NYSE: NVS) Scemblix (asciminib).
Further data from randomized dosing cohorts receiving 60 mg and 120 mg ELVN-001 (total n=41) revealed even higher response rates, with MMR achievement at 53% and DMR at 35%, underscoring the potential efficacy across different dosage levels.
Cumulatively, across all Phase 1b dosing groups, it was observed that 100% of the evaluable patients who had MMR at the time of enrollment either maintained or improved their molecular response during the trial duration. This outcome indicates sustained efficacy in this patient population.
Regarding safety observations, ELVN-001 showed clinical activity across the investigated doses ranging from 60 mg to 120 mg once daily. Importantly, the trial data did not reveal a distinct dose-response relationship in either therapeutic benefit or adverse events within this dosage range.
The safety profile remained consistent with prior reports, with no maximum tolerated dose established to date. Additionally, no novel safety signals were identified, and the tolerability of ELVN-001 was considered favorable throughout the evaluated doses, an encouraging indicator for future development stages.
Looking forward, Enliven Therapeutics has announced plans to initiate the ENABLE-2 Phase 3 trial for ELVN-001 in the latter half of 2026. This subsequent study will presumably build upon these Phase 1b findings in a larger patient cohort to further establish efficacy and safety benchmarks required for potential regulatory approval.
Following the announcement of these positive clinical outcomes, the company's stock price rose sharply by 50.42%, reaching $23.27 at publication time, reflecting strong market reception to the trial data.
Overall, these results highlight significant progress for Enliven Therapeutics in advancing ELVN-001 as a potential therapeutic in CML cases with limited options due to resistance or intolerance to existing TKIs.