Enliven Therapeutics Inc. (NASDAQ:ELVN) stock is trading higher on Thursday, with a session volume of 6.61 million compared to the average volume of 631.52 thousand as per data from Benzinga Pro.
The clinical-stage biopharmaceutical company shared encouraging initial data from the ongoing Phase 1b ENABLE trial of ELVN-001 in patients with chronic myeloid leukemia (CML) that is relapsed, refractory, or intolerant to available tyrosine kinase inhibitors (TKIs).
Data
As of the cutoff date of December 22, 2025, 60 heavily pre-treated patients were enrolled.
In the 80 mg QD Phase 1b cohort (n=19), all patients were evaluable for efficacy by 24 weeks.
The rates in these mature data of major molecular response (MMR) achievement (38%) and Deep Molecular Response (DMR) (16%) compare favorably to precedent Phase 1 trials of approved BCR::ABL1 TKIs, including Novartis AG’s (NYSE:NVS) Scemblix (asciminib).
In the randomized 60 mg and 120 mg cohorts (n=41), highly encouraging rates of MMR achievement (53%) and DMR (35%) were observed.
Across all Phase 1b cohorts, 100% of evaluable patients in MMR at enrollment maintained, or deepened, their response.
Safety And Efficacy
As expected, clinical activity was observed at doses from 60 mg to 120 mg QD, with no clear evidence of dose response (efficacy or safety) within this range.
ELVN-001 continues to demonstrate a favorable safety and tolerability profile across all evaluated doses. The safety profile observed in these Phase 1b cohorts remained consistent with previously reported data, with no maximum tolerated dose and no new safety signals identified.
The company plans to initiate the ENABLE-2 Phase 3 trial of ELVN-001 in the second half of 2026.
ELVN Price Action: Enliven Therapeutics shares were up 50.42% at $23.27 at the time of publication on Thursday, according to Benzinga Pro data.
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