NEW YORK, New York — October 7, 2025 — Leads & Copy — Lexeo Therapeutics, Inc. (Nasdaq: LXEO) announced updates to an Accelerated Approval pathway for LX2006 in Friedreich ataxia (FA) cardiomyopathy, alongside new interim clinical data from ongoing Phase I/II studies. The FDA is open to pooling data from ongoing Phase I/II studies of LX2006 with pivotal data to support a Biologics License Application (BLA) for Accelerated Approval.
Interim clinical data show improvements in the majority of participants across cardiac and neurologic measures of Friedreich ataxia. Participants with abnormal left ventricular mass index (LVMI) at baseline achieved an 18% mean reduction in LVMI at 6 months and a 23% mean reduction at 12 months, exceeding the FDA-aligned target threshold of a 10% reduction. A clinically meaningful improvement was observed in the modified Friedreich Ataxia Rating Scale (mFARS), indicative of slowed disease progression and improved function.
Lexeo plans to initiate the LX2006 pivotal study as soon as possible in the first half of 2026, pending finalization of the trial protocol.
R. Nolan Townsend, CEO of Lexeo Therapeutics, stated that the company is encouraged by its recent dialogue with the FDA on LX2006 and appreciates the agency’s collaborative spirit.
Media Contact: Media@lexeotx.com
Investor Contact: Carlo Tanzi, Ph.D., ctanzi@kendallir.com
Source: Lexeo Therapeutics
