Enliven Therapeutics Inc (ELVN) News & EventsELVNEnliven Therapeutics Inc

Enliven Therapeutics Aligns with FDA on ENABLE-2 Trial Design

Enliven Therapeutics announced that it has reached alignment with the U.S. FDA on the final design of the ENABLE-2 pivotal trial, a Phase 3 trial of relcobatinib in patients with previously treated chronic myeloid leukemia. United States Adopted Names Council has adopted relcobatinib as the nonproprietary name for ELVN-001. Relcobatinib is an investigational, potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, the oncogenic driver of CML. The company remains on track to initiate ENABLE-2 before year-end 2026.

Enliven Cash and Securities Reach $895.2M, Preparing to Advance ELVN-001

As of June 30, 2026, the Company had cash, cash equivalents and marketable securities totaling $895.2M, which is expected to provide cash runway into 2030. "Q2 was an important period for Enliven as we announced compelling updated clinical data for ELVN-001, reached alignment with the FDA on key components of the ENABLE-2 Phase 3 2L+ trial design, and significantly strengthened our balance sheet," said CEO Rick Fair. "The updated Phase 1 data support ELVN-001's potential to become a best-in-class treatment for patients living with CML. Combined with our recent regulatory and financial progress, we are well positioned to initiate ENABLE-2 later this year and rapidly advance ELVN-001 across all lines of CML therapy."

Enliven Stock Rises 9.9% to $44.37

Enliven is up 9.9%, or $4.01 to $44.37.