By Chris Wack

Lexeo Therapeutics shares were 17% higher, at $4.78, after the company said that the Food and Drug Administration has granted breakthrough therapy designation to gene therapy LX2006 based on clinical evidence generated on both cardiac and neurologic measures of Friedreich's ataxia.

The clinical stage genetic medicine company said LX2006 has also been selected to participate in the FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program, intended to enable earlier patient access to therapies with expedited clinical development timelines.

To date, 17 participants have been treated across two trials, and Lexeo is currently enrolling a prospective natural history study, which will serve as a concurrent external control arm for the registrational study.

The company expects to initiate the registrational study by early 2026 and is actively working with FDA to finalize the statistical analysis plan.

Breakthrough Therapy designation is intended to accelerate the development and review of investigational therapies that aim to treat serious or life-threatening diseases and where preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over available alternatives.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

July 30, 2025 12:46 ET (16:46 GMT)

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