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Lexeo Therapeutics Says FDA Granted Breakthrough Therapy Designation for Potential Drug for Friedreich's Ataxia
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Lexeo Therapeutics Says FDA Granted Breakthrough Therapy Designation for Potential Drug for Friedreich's Ataxia
Jul 7, 2025 5:37 AM

08:12 AM EDT, 07/07/2025 (MT Newswires) -- Lexeo Therapeutics ( LXEO ) said Monday the US Food and Drug Administration has granted breakthrough therapy designation to LX2006, the company's gene therapy candidate for Friedreich's ataxia, a rare and progressive neurodegenerative disease.

The designation was based on interim clinical data showing meaningful improvements in both cardiac and neurologic function.

The company said the healthy agency also selected LX2006 for its CMC Development and Readiness Pilot program to accelerate chemistry, manufacturing and controls review for therapies with expedited clinical timelines.

Shares of the company rose more than 3% in Monday's premarket activity.

Price: 4.60, Change: +0.15, Percent Change: +3.37

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