ELVN - EHA Update Confirms Compelling Efficacy/Safety Profile in CML; Well-Positioned for Planned Phase 3 Post-FDA Meeting

研报英文原文证据摘录

ELVN - EHA Update Confirms Compelling Efficacy/Safety Profile in CML; Well-Positioned for Planned Phase 3 Post-FDA Meeting

FLASH NOTE

June 11, 2026

Michael Schmidt, Ph.D. michael.schmidt@guggenheimpartners.com ELVN - EHA Update Confirms Compelling Efficacy/

617 859 4636 Safety Profile in CML; Well-Positioned for Planned

Sarah Bi, Ph.D.

sarah.bi@guggenheimpartners.com Phase 3 Post-FDA Meeting

857 350 0123

Paul Jeng, Ph.D. Key Message: ELVN presented updated Phase 1b data on BCR-ABL TKI, ELVN-001, in

paul.jeng@guggenheimpartners.com 2L+ CML in advance of their EHA presentation today. Both efficacy and safety data in now 617 859 4618

more patients dosed at relevant doses, in our view, continue to look highly compelling,

Rosy Liao, Ph.D. consistent with data highlighted previously and should incrementally increase investor

rosy.liao@guggenheimpartners.com confidence in planned Phase 3 registration studies. ELVN also confirmed alignment with

617 859 4663 the FDA on a broad 2L+ CML Phase 3 study design (ENABLE-2 study) after at least

1 prior TKI where ELVN-001 80mg QD will be randomized vs. 1/2G BCR-ABL TKIs,

reflecting a highly likely beatable efficacy bar, in our view. Management reaffirmed plans

ELVN forterma safety1L CMLdataPhaseand efficacy3 study fromto launcha Ph in1 studyearly 2028,in 1L CMLpendingnextgenerationyear, which,of longerin our

Enliven Therapeutics, Inc. view, positions ELVN-001 well to address a potential $15Bn US TAM across all lines of

Sector: Biotechnology CML therapy, per our analysis (see here). We maintain our high-conviction BUY rating

following today's disclosure and believe the current $2.6Bn market valuation prices in

Company Update only highly discounted revenue expectations relative to ELVN-001's peak sales potential,