Based on the Phase I/II results, the FDA indicated in October that it is open to an accelerated approval pathway, including discussions around a Biologics License Application for LX2006. Pivotal data are expected in 2027, and Lexeo plans to initiate the registrational study in the first half of 2026, pending finalization of the trial protocol.The company’s leading program is LX2006, an AAV-based gene therapy designed to treat Friedreich’s ataxia cardiomyopathy by delivering a functional frataxin gene via in ...