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Lexeo Therapeutics Announces Progress in FDA Discussions for Accelerated Approval Pathway and Positive Interim Clinical Data for LX2006 in Friedreich Ataxia Cardiomyopathy
U.S. Food and Drug Administration (FDA) open to pooling data from ongoing Phase I/II studies of LX2006 with pivotal data to support a Biologics License Application (BLA) for Accelerated Approval Interim clinical data show sustained or deepening improvements in the majority of participants across both cardiac and neurologic measures of Friedreich ataxia Participants with abnormal left ventricular mass index (LVMI) at baseline achieved 18% mean reduction in LVMI at 6 months and 23% mean reduction
About this update from Lexeo Therapeutics, Inc.
[{"type":"image","alt":"Lexeo Therapeutics","displaySize":"","headline":null,"caption":"Lexeo Therapeutics","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":116,"url":"https://media.zenfs.com/en/globenewswire.com/12a596ea7105503183002156834260ac"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/ZNNLd9kZ10lMRyd7r.aoKQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE2MjtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/12a596ea7105503183002156834260ac","width":300,"height":116}},"lazy":false},{"type":"text","content":"U.S. Food and Drug Administration (FDA) open to pooling data from ongoing Phase I/II studies of LX2006 with pivotal data to support a Biologics License Application (BLA) for Accelerated Approval","length":194,"tagName":"p"},{"type":"text","content":"Interim clinical data show sustained or deepening improvements in the majority of participants across both cardiac and neurologic measures of Friedreich ataxia","length":159,"tagName":"p"},{"type":"text","content":"Participants with abnormal left ventricular mass index (LVMI) at baseline achieved 18% mean reduction in LVMI at 6 months and 23% mean reduction at 12 months, exceeding FDA-aligned target threshold of 10% reduction","length":214,"tagName":"p"},{"type":"text","content":"Clinically meaningful improvement observed in the modified Friedreich Ataxia Rating Scale (mFARS), indicative of slowed disease progression and improved function","length":161,"tagName":"p"},{"type":"text","content":"Company to host webcast today at 8:00 AM ET","length":43,"tagName":"p"},{"type":"text","content":"NEW YORK, Oct. 07, 2025 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering novel treatments for cardiovascular diseases, today announced updates to key components of an Accelerated Approval pathway for LX2006 in Friedreich ataxia (FA) cardiomyopathy, alongside new interim clinical data from ongoing Phase I/II studies.","length":395,"tagName":"p"},{"type":"text","content":"“We are encouraged by our recent dialogue with the FDA on LX2006, and we appreciate the Agency’s collaborative spirit as we work to deliver a potentially life-changing therapy to the FA community as efficiently as possible,” said R. Nolan Townsend, Chief Executive Officer of Lexeo Therapeutics. “Given the highly compelling data to date tha...