Lexeo Therapeutics (LXEO) has finalized a pivotal study design to evaluate gene therapy candidate LX2006 in Friedreich ataxia cardiomyopathy, the company said Monday.

The trial protocol and statistical analysis plan are intended to provide clinical evidence to support the submission of a biologics license application to the US Food and Drug Administration for the therapy under the accelerated approval pathway in 2028, according to a statement.

Lexeo said it remains in ongoing discussions with the agency regarding the confirmatory evidence strategy for the study.

The company added that it expects a topline data readout in H2 of 2027 and a biologics license application submission under the accelerated approval pathway in H1 of 2028.