Lexeo Therapeutics Announces Key FDA Updates and New Interim Data for LX2006 in Friedreich Ataxia Cardiomyopathy, Paving Way for Accelerated Approval Pathway

Reuters
10/07
<a href="https://laohu8.com/S/LXEO">Lexeo Therapeutics</a> Announces Key FDA Updates and New Interim Data for LX2006 in Friedreich Ataxia Cardiomyopathy, Paving Way for Accelerated Approval Pathway

Lexeo Therapeutics Inc. (Nasdaq: LXEO) has announced updates on the development strategy for its investigational gene therapy, LX2006, targeting Friedreich ataxia $(FA)$ cardiomyopathy. The company reported that the U.S. Food and Drug Administration (FDA) is open to a Biologics License Application (BLA) submission for accelerated approval, allowing the pooling of clinical data from ongoing Phase I/II studies with forthcoming data from a planned pivotal trial. To support this approach, Lexeo will submit enhanced manufacturing comparability data and fulfill an additional nonclinical requirement prior to the pivotal study, reflecting the transition to its optimized Sf9-baculovirus manufacturing platform. The FDA has also agreed to evaluate the co-primary endpoint of left ventricular mass index (LVMI) at an earlier time point than previously planned. Interim clinical data from the Phase I/II studies were presented, and Lexeo will host a webcast to discuss these updates, with materials to be available on the company's website.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Lexeo Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9540773-en) on October 07, 2025, and is solely responsible for the information contained therein.

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