Lexeo Therapeutics finalizes SUNRISE-FA 2 pivotal trial design for LX2006 gene therapy

Lexeo Therapeutics announced finalization of the SUNRISE-FA 2 pivotal trial protocol for LX2006 in Friedreich ataxia, with first patient enrollment expected by end of Q2 2026 and BLA submission targeted for 2028. The open-label study design with 13 treated and 13 untreated control participants positions the company toward potential accelerated FDA approval for the first gene therapy treatment in this indication.