Enliven Therapeutics Inc. (ELVN) shares rocketed higher on Thursday, and it's not hard to see why. The clinical-stage biotech company delivered exactly what investors want to hear: promising early data that suggests its experimental drug might actually work. Trading volume hit 6.61 million shares, more than ten times the typical daily average of 631,520 shares.
The excitement centers on initial results from the ongoing Phase 1b ENABLE trial of ELVN-001, which targets patients with chronic myeloid leukemia (CML) that has either relapsed, proven resistant to existing treatments, or caused intolerable side effects with available tyrosine kinase inhibitors.
The Numbers Look Good
As of the December 22, 2025 data cutoff, 60 heavily pre-treated patients had enrolled in the trial. These weren't easy cases—these were patients who had already cycled through multiple treatment options.
In the mature 80 mg daily dose cohort of 19 patients (all evaluable for efficacy by 24 weeks), the drug achieved a 38% major molecular response rate and 16% deep molecular response rate. Those figures stack up favorably against precedent Phase 1 trials of approved BCR::ABL1 TKIs, including Novartis AG's (NVS) Scemblix (asciminib), which is already on the market.
The randomized cohorts testing 60 mg and 120 mg doses showed even more encouraging results. Among those 41 patients, major molecular response rates hit 53%, while deep molecular response rates reached 35%. Perhaps most impressive: every evaluable patient who entered the trial already in major molecular response either maintained or improved their response—a 100% success rate on that metric.