Lexeo's LX2006 Gene Therapy Gets FDA Fast Track Designation; Stock Up In Pre-market

(RTTNews) - Lexeo Therapeutics, Inc. (LXEO), a clinical stage genetic medicine company, announced Tuesday that the U.S. Food and Drug Administration has granted Fast Track designation to LX2006 gene therapy.

In pre-market activity on the Nasdaq, Lexeo shares were gaining around 5.8 percent to trade at $12.79.

LX2006 is an AAV-based gene therapy candidate delivered intravenously for the treatment of FA cardiomyopathy, the most common cause of mortality in patients with FA.

LX2006 is designed to deliver a functional frataxin gene to promote frataxin protein expression and restore mitochondrial function in myocardial cells.

The Fast Track designation was granted based on available preclinical data.

The FDA's Fast Track is a process designed to facilitate the development and expedite the review of new drugs intended to treat serious conditions and address unmet medical need.

The company noted that SUNRISE-FA, a Phase 1/2 multicenter, 52-week, dose-ascending, open-label clinical trial, is ongoing to evaluate the safety and tolerability, as well as preliminary efficacy, of LX2006 in patients with FA cardiomyopathy.

Nolan Townsend, Chief Executive Officer of Lexeo, said, "FA cardiomyopathy is the leading cause of death among FA patients, and there are currently no approved treatment options. The FDA's Fast Track designation for LX2006 underscores the significant unmet need for effective treatment options to address the cardiac impact of this debilitating disease."

Previously, Rare Pediatric Disease and Orphan Drug designations were granted to LX2006.

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