Enliven Therapeutics’ Initial Leukemia Drug Data Excite Investors, Shares Surge

Enliven Therapeutics Inc. (NASDAQ: ELVN) Sees Significant Stock Surge

On Thursday, shares of Enliven Therapeutics Inc. (NASDAQ: ELVN) experienced a notable increase in trading activity, with 6.61 million shares exchanged—far surpassing the typical daily average of 631,520, according to Benzinga Pro.

Promising Results from ELVN-001 Clinical Trial

The biopharmaceutical company, which is focused on clinical-stage research, recently released encouraging preliminary findings from its ongoing Phase 1b ENABLE study. This trial is evaluating ELVN-001 in patients with chronic myeloid leukemia (CML) who have either relapsed, are resistant, or cannot tolerate currently available tyrosine kinase inhibitors (TKIs).

Key Data Highlights

• As of December 22, 2025, a total of 60 patients with extensive prior treatment had been enrolled in the study.
• In the 80 mg once-daily (QD) Phase 1b group (n=19), all participants were assessed for efficacy at the 24-week mark.
• Major molecular response (MMR) was achieved by 38% of these patients, while 16% reached a deep molecular response (DMR). These outcomes compare favorably to previous Phase 1 studies of approved BCR::ABL1 TKIs, such as Novartis AG’s Scemblix (asciminib).
• Among patients in the randomized 60 mg and 120 mg groups (n=41), MMR was observed in 53% and DMR in 35% of cases.
• All patients who had achieved MMR at the start of the trial maintained or improved their response throughout the Phase 1b cohorts.

Safety and Tolerability

Clinical activity was evident at doses ranging from 60 mg to 120 mg QD, with no clear dose-dependent trends in efficacy or safety within this range. ELVN-001 continued to show a strong safety and tolerability profile across all tested doses. The safety results were consistent with earlier reports, with no maximum tolerated dose reached and no new safety concerns identified.

Next Steps

Enliven Therapeutics intends to begin the ENABLE-2 Phase 3 trial for ELVN-001 in the latter half of 2026.

Stock Performance

ELVN Price Movement: At the time of reporting on Thursday, Enliven Therapeutics shares had climbed 50.42% to $23.27, as per Benzinga Pro data.

Image credit: Yomal2233 via Shutterstock

Stock Snapshot

• ELVN (Enliven Therapeutics Inc.): $23.25, up 50.3%
• NVS (Novartis AG): $141.31, down 0.47%