Lexeo Therapeutics Stock Rallies On Discussions With FDA To Expedite Friedreich’s Ataxia Drug Approval Process

The company stated that data from a planned pivotal study will be pooled with data from the ongoing Phase I/II studies of LX2006 to support an approval application to the U.S. Food and Drug Administration for the therapy.

Lexeo Therapeutics (LXEO) announced on Tuesday that the company is considering a smaller pivotal study for LX2006 in the treatment of Friedreich's ataxia (FA) cardiomyopathy, scheduled to begin in the first half of 2026, pending finalization of the study protocol.

The data from the planned pivotal study will be pooled with data from the ongoing Phase I/II studies of LX2006 to support an approval application to the U.S. Food and Drug Administration for the therapy, the company stated after discussions with the agency.

Lexeo will submit enhanced manufacturing comparability data and meet an additional nonclinical requirement before the initiation of the planned pivotal study to enable pooling, the company added.

Lexeo is continuing to engage with the agency regarding the protocol of the pivotal study, it stated, adding that it believes this regulatory feedback has the potential to reduce the size and duration of the planned pivotal study. The company is also optimistic that the feedback may accelerate the overall timeline to an application submission.

Updated interim clinical data from both ongoing Phase I/II studies of LX2006 show sustained or deepening improvements in the majority of participants across both cardiac and neurologic measures of Friedreich’s ataxia, the company said.

FA cardiomyopathy is the leading cause of death in individuals with Friedreich’s ataxia (FA), a rare, inherited neurodegenerative disorder causing progressive damage to the nervous system, leading to impaired balance, muscle coordination, and sensory loss, often beginning in childhood. It is estimated to affect approximately 5,000 people in the U.S.

Shares of the company rallied 24% at the time of writing. On Stocktwits, retail sentiment around LXEO stock jumped from ‘bearish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume rose from ‘low’ to ‘extremely high’ levels.

LXEO stock has risen 22% this year and but fallen by approximately 6% over the past 12 months. 

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