Lexeo Therapeutics said FDA feedback could allow an accelerated approval pathway for LX‑2006, its gene therapy for Friedreich’s ataxia cardiomyopathy, if patient data from multiple ongoing studies are pooled. Interim clinical data reportedly showed cardiac and neurologic improvements; Lexeo said the agency suggested a path that could lead to earlier BLA submission with pooled evidence. The company’s stock jumped on the prospect of a speeded regulatory track. Regulatory openness to pooled datasets for rare disease gene therapies would be consequential—shortening timelines for ultra‑orphan programs and shaping sponsor strategies across the gene therapy field. Lexeo plans to continue pivotal runs while engaging regulators on the proposed submission design.