Lexeo Therapeutics: Quick Take on the Regulatory Update for LX2006

研报英文原文证据摘录

Lexeo Therapeutics: Quick Take on the Regulatory Update for LX2006

J P M O R G A N North America Equity Research

16 June 2026

Lexeo Therapeutics Overweight

LXEO, LXEO US

Quick Take on the Regulatory Update for LX2006 Price (16 Jun 26):$4.75

SMid Biotechnology

Notably, Lexeo has now finalized the SUNRISE-FA 2 pivotal trial protocol and Tessa T Romero AC

statistical analysis plan to support the submission of a BLA for LX2006 in Friedreich’s (1-212) 622-4484

ataxia (FA) cardiomyopathy under the accelerated approval (AA) pathway; tessa.t.romero@jpmchase.com

specifically, the open-label SUNRISE-FA 2 study will enroll 13 patients aged 16yo+ Caroline Pocher

who will receive a single IV administration of LX2006 (1.2E12 vector genomes per (1-212) 622-8204

kilogram) compared with 13 patients untreated with LX2006 (untreated control; no caroline.pocher@jpmchase.com

placebo or sham). The primary endpoint of the trial is LVMI assessed via cardiac MRI Mariam Waggeh

with a topline efficacy readout at 6mo post-treatment; the SAP is powered to detect (1-212) 622-1711

mariam.waggeh@jpmchase.com

an LVMI effect size of 15% or greater. Interestingly, the FDA recommended the J.P. Morgan Securities LLC

removal of the cardiac frataxin (FXN) protein expression co-primary endpoint as it

was determined to be “no longer necessary to demonstrate proof of mechanism for

LX2006.” Secondary endpoints are expected to include measures of neurologic and

cardiac outcomes and relevant biomarkers, including modified Friedreich Ataxia

Rating Scale (mFARS), Kansas City Cardiomyopathy Questionnaire (KCCQ), high-

sensitivity (hs) troponin-I, and lateral wall thickness. Topline results from the study

are expected in 2H27 (first patient anticipated to enroll this month) and a BLA

submission is targeted for 1H28.