Lexeo Therapeutics said U.S. FDA discussions positioned its LX‑2006 gene therapy for Friedreich ataxia (FA) to pursue an accelerated approval pathway if the company submits pooled data from ongoing Phase I/II studies. The agency signaled that combining datasets could support a faster biologics license application (BLA) if clinical and safety thresholds are met. LX‑2006 is a one‑time intravenous gene therapy aimed at treating cardiomyopathy and neurologic deficits in FA. Lexeo reported interim improvements in cardiac and neurologic measures in treated patients, prompting management to engage regulators about an accelerated path built on surrogate endpoints and pooled pivotal evidence. FDA openness to pooled submissions illustrates regulatory flexibility for rare‑disease gene therapies and sets a possible precedent for other single‑infusion cardiomyopathy and neurologic programs.