Enliven Therapeutics (ELVN) said Thursday that it has reached alignment with the US Food and Drug Administration on the 80 mg once daily dose of ELVN-001 in a planned late-stage trial for chronic myeloid leukemia.

The company said the trial will enroll patients with chronic myeloid leukemia who have previously been treated with one or more tyrosine kinase inhibitors, or TKIs, and will receive either ELVN-001 or the physician's choice of ATP-competitive TKI.

Enliven said additional details on late-stage trial design will be finalized after another meeting with the FDA in Q3, with the study set to begin in the second half of this year.

Enliven also published data from the first phase of the study. In the 80 mg QD phase 1b cohort, the overall major molecular response by 24 weeks was 61%, with 67% in patients who had previously received one or two unique TKIs, it said.

Shares of the company were up 22% in recent Thursday premarket activity.