Lexeo gets FDA feedback for LX2006 accelerated approval; interim data show LVMI reduction, mFARS improvement

Lexeo Therapeutics, Inc.

FDA open to pooling ongoing Phase 1/2 data with pivotal study to support BLA for accelerated approval.
Abnormal-LVMI patients (n=6): 18% mean reduction at 6 months, 23% at 12 months, exceeding 10% FDA threshold.
All participants (n=16) >6-mo follow-up: 2.0-point mean mFARS improvement; 11 of 16 improved or stabilized.
LX2006 generally well tolerated; no Grade 3+ SAEs; no discontinuations; one Grade 2 asymptomatic myocarditis.
Lexeo plans to initiate LX2006 pivotal study as soon as possible in first half of 2026.

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