Lexeo Therapeutics reaches FDA alignment on development plan for LX2006

LX2006 for the Treatment of FA Cardiomyopathy: Regulatory Update: Alignment on key elements of accelerated development pathway following a Type C meeting with the U.S. Food and Drug Administration: Increase in frataxin expression and reduction in left ventricular mass index as co-primary registrational endpoints to support accelerated approval; Target levels including 10% reduction in LVMI and 40% frataxin positive area as measured by immunohistochemistry; Histology-based measurement of frataxin and cardiac MRI as acceptable measurement tools; Use of secondary endpoints including left ventricular wall thickness and troponin as supportive measures of efficacy; Enrollment of participants with elevated LVMI in pivotal trial; Final dose selection and size of registrational trial alignment expected in 2025 guided by cohort 3 cardiac biopsy results