Enliven Therapeutics, Inc. 8K

Enliven Therapeutics reported positive Phase 1 ENABLE data for ELVN-001 in CML and obtained FDA alignment on dose and patient population for its planned ENABLE-2 Phase 3 trial.

On June 11, 2026, Enliven Therapeutics, Inc. announced updated positive Phase 1 clinical data from its ENABLE trial of ELVN-001 in previously treated chronic myeloid leukemia patients and reported that it had reached alignment with the U.S. Food and Drug Administration on key elements of the planned ENABLE-2 pivotal Phase 3 trial, including selection of 80 mg once-daily as the recommended Phase 3 dose and the inclusion of second-line and later patients (those with at least one prior TKI), supported by favorable major molecular response rates and a tolerable safety profile in a heavily pretreated population of 161 patients with a median treatment duration of 35 weeks.

Filing Facts

CIK

1672619

Ticker

ELVN

Form

8K

Source Type

sec

Accession

0001193125-26-266731

Alert Tier

6