ELVN Enliven Therapeutics, Inc.

Price Chart

Executive Summary

Enliven Therapeutics reported updated positive Phase 1 data for ELVN-001 in CML, showing a 61% overall MMR and 48% MMR achievement by 24 weeks in the 80 mg QD cohort, with a favorable safety profile (6% discontinuation rate). The company also announced FDA alignment on the 80 mg QD dose and the 2L+ patient population for the planned Phase 3 ENABLE-2 trial, expected to initiate in H2 2026. This is a significant clinical and regulatory milestone that de-risks the program and supports a clear path to pivotal development.

Actionable Insight

Key Facts

• 61% overall MMR and 48% MMR achievement by 24 weeks in the 80 mg QD Phase 1b cohort (n=28 evaluable).
• 67% overall MMR and 55% MMR achievement by 24 weeks in all Phase 1b patients with 1-2 prior TKIs.
• FDA alignment on 80 mg QD as the recommended Phase 3 dose and on the 2L+ patient population for ENABLE-2.
• ENABLE-2 pivotal trial expected to initiate in the second half of 2026.
• Favorable safety profile: 6% discontinuation rate due to AEs; Grade 3 TEAEs in 24% of patients at 80 mg QD.
• 161 patients enrolled as of March 10, 2026 cutoff; 76% remain on study with median treatment duration of 35 weeks.
• Prior asciminib exposure did not meaningfully impact response rates.

Financial Impact

No financial data provided in the filing. The clinical milestone supports potential future revenue from ELVN-001 if approved, but no revenue or earnings figures are disclosed.

Risk Factors

• Phase 3 trial may fail to replicate Phase 1 results in a larger, randomized setting.
• Competition from approved TKIs (e.g., asciminib, ponatinib) and other pipeline candidates.
• Regulatory delays or changes in trial design requirements from the FDA.
• Enliven is a clinical-stage company with no approved products or revenue, dependent on capital markets for funding.

Market Snapshot

Documents Analyzed

This report is based on 5 SEC documents filed with EDGAR.

US Market Status