Lexeo Soars on FDA Signal for Gene Therapy Fast-Track
Shares surge over 30% after the FDA indicated an accelerated approval pathway may be open for Lexeo's Friedreich's ataxia gene therapy candidate, LX2006.
Lexeo Therapeutics (NASDAQ: LXEO) saw its shares jump significantly after announcing progress in its discussions with the U.S. Food and Drug Administration (FDA). The regulatory agency has indicated it is open to considering an for LX2006, the company's experimental gene therapy for Friedreich's ataxia cardiomyopathy.
The news, which could shorten the timeline to market for this key pipeline asset, sent Lexeo's stock soaring by as much as 30% in early trading. This positive feedback from the FDA allows Lexeo to potentially pool data from its ongoing Phase 1/2 studies with results from a planned pivotal trial, which could expedite the development and review process.
Lexeo also reported encouraging interim data from its ongoing clinical trials. The studies showed that LX2006 led to a reduction in Left Ventricular Mass Index (LVMI), a key measure of the heart's size and function. These positive results, coupled with the FDA's willingness to consider an accelerated path, have been well-received by investors and analysts alike. In response to the news, H.C. Wainwright on LXEO stock, citing an increased probability of approval for the drug.
Friedreich's ataxia is a rare, inherited disease that causes progressive damage to the nervous system and heart. The potential for a new, effective treatment has been a long-awaited development for patients and their families. To that end, the FDA has already granted LX2006 multiple special designations, including Breakthrough Therapy and Fast Track, to help speed up its journey to market. Lexeo now plans to initiate a pivotal study for the drug in the first half of 2026, with the potential for a smaller and shorter trial due to the FDA's recent feedback.
The company's progress with LX2006 is a significant step forward in the field of gene therapy and offers hope to those affected by this devastating disease. With a clearer regulatory path and , Lexeo is well-positioned to advance this promising treatment toward a potential approval.