Enliven sticks to year-end ENABLE-2 start after FDA alignment on CML trial design
Enliven Therapeutics said it remains on track to begin the Phase 3 ENABLE-2 trial of relcobatinib before year-end 2026, with $884.4 million in cash to fund operations into 2030.
Enliven Therapeutics reported third quarter 2026 financial results on November 5, 2026, reiterating that it remains on track to initiate the ENABLE-2 trial before year-end 2026. The company remains on track to initiate ENABLE-2 before year-end 2026.1
The trial's design was finalized with regulators. Enliven reached alignment with the U.S. Food and Drug Administration on the final design of the ENABLE-2 pivotal trial of relcobatinib in patients with previously treated chronic myeloid leukemia (CML).1 The study is a planned randomized Phase 3 trial of relcobatinib in adults with CML previously treated with one or more TKIs, expected to enroll approximately 450 patients, who will be randomized 1:1 to receive relcobatinib 80 mg once daily or an investigator-selected second-generation TKI (dasatinib, nilotinib, or bosutinib).1 The primary endpoint is major molecular response (MMR) at Week 24, which could support accelerated approval, with MMR at Week 96 serving as the key secondary endpoint that could support full approval.1
The company also noted continued scientific engagement around the drug. Clinical data for relcobatinib from the Phase 1 ENABLE trial were featured in encore oral presentations at meetings of the Society of Hematologic Oncology, the International CML Foundation, the Japanese Society of Hematology and the German Society for Hematology and Medical Oncology.1 Separately, the United States Adopted Names Council adopted relcobatinib as the nonproprietary name for ELVN-001.1
On the corporate side, Enliven appointed Kristine Ball, an accomplished biopharmaceutical executive, to its Board of Directors.1
Financially, as of September 30, 2026, the Company had cash, cash equivalents and marketable securities totaling $884.4 million, which is expected to provide cash runway into 2030.1 Enliven reported a net loss of $27.7 million for the third quarter of 2026, compared to a net loss of $20.1 million for the third quarter of 2025.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.