Enliven clears trial blueprint with FDA for CML drug, funded into 2030

Enliven Therapeutics has settled the shape of its pivotal programme for relcobatinib, also known as ELVN-001, after reaching alignment with the US Food and Drug Administration on the final design of ENABLE-2. The randomised Phase 3 study will test the drug in people with chronic myeloid leukaemia (CML) who have already received treatment.

The trial is planned to enrol around 450 patients and uses major molecular response at week 24 as its primary endpoint. Enliven says it expects that measure could support an application for accelerated approval. The company said it still plans to begin the study before the end of 2026.

The disclosure came with Enliven's third-quarter 2026 results, which showed cash of $884.4m and a quarterly net loss of $27.7m. The company said its cash runway should stretch into 2030, which on its own guidance would cover the planned trial period.

The information available does not specify the comparator arm, eligibility criteria or when data might be reported, so it is not possible to say how the study will be positioned against existing CML therapies or when it could produce results. Agreement on design also does not guarantee an approval decision.