ELVN Stock Shot Up 60% Today – What’s Driving The Rally?

The company reported positive initial data from its ongoing Phase 1b clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia.

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Arnab Paul·Stocktwits

Updated Jan 08, 2026 | 11:41 AM EST

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As of Dec. 22, 2025, 60 heavily pretreated patients were enrolled, and ELVN-001 delivered strong efficacy by 24 weeks.
Enliven plans to present additional Phase 1 data in mid-2026.
The company plans to initiate the Phase 3 ENABLE-2 trial in the second half of 2026.

Enliven Therapeutics (ELVN) stock surged as high as 60% on Thursday after the company reported positive initial data from its ongoing Phase 1b ENABLE clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia (CML).

ELVN shares jumped to their highest levels in more than a year on Thursday before paring some of those gains.

ELVN-001 is a highly selective small-molecule inhibitor designed to directly target the BCR::ABL gene fusion, the key disease driver in CML. As of Dec. 22, 2025, 60 heavily pretreated patients had been enrolled in the study, with more than half having received four or more prior tyrosine kinase inhibitors (TKIs), including Asciminib and Ponatinib medications. ELVN-001 showed strong efficacy by 24 weeks.

In the initial 80 mg once-daily cohort, 38% of patients achieved a major molecular response (MMR), while 16% reached a deep molecular response (DMR). In the randomized 60 mg and 120 mg cohorts, MMR and DMR rates rose to 53% and 35%, respectively. All patients who entered the study already in MMR maintained or improved their responses.

The drug demonstrated consistent activity across doses from 60 mg to 120 mg, with no clear dose-response differences observed. Importantly, ELVN-001 was well tolerated, with no maximum tolerated dose identified and no new safety concerns reported.

2026 Pipeline

Enliven plans to present additional Phase 1 data in mid-2026, align with the FDA on dose selection and Phase 3 design, and initiate the Phase 3 ENABLE-2 trial in the second half of 2026.

“Momentum has been building over the last year leading to significant interest in our Phase 3 clinical trial from sites all around the world. We are preparing for upcoming regulatory interactions with the FDA to align on dose selection and support initiation of the Phase 3 trial in the second half of 2026,” said Helen Collins, M.D., Chief Medical Officer of Enliven.