07:23 AM EDT, 10/07/2025 (MT Newswires) -- Lexeo Therapeutics ( LXEO ) said Tuesday the US Food and Drug Administration has indicated openness to a biologics license application submission for accelerated approval of its LX2006 candidate for the treatment of Friedreich ataxia cardiomyopathy.

The submission will include interim clinical data from ongoing phase I/II studies of LX2006 pooled with new clinical data to be generated in a pivotal study that Lexeo said it plans to initiate "as soon as possible" in H1 2026.

The company said interim clinical data of LX2006 showed improvements in most participants across both cardiac and neurologic measures of Friedreich ataxia, a rare neurodegenerative disorder.

Lexeo shares were up 31% in recent premarket activity.