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... Read More

Breakthrough Therapy designation granted for LX2006 based on interim data from Phase I/II trials demonstrating clinically meaningful improvements in cardiac and neurologic measures of Friedreich ataxia LX2006 selected for FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) program, created to facilitate CMC registrational readiness and support faster patient access Eight participants dosed in... Read More

Breakthrough Therapy designation based on interim clinical data from Phase I/II trials showing clinically meaningful improvements in cardiac biomarkers and functional measures LX2006 also selected for FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) program, created to facilitate CMC registrational readiness and support faster patient access NEW YORK, July 07, 2025 (GLOBE NEWSWIRE) -- Lexeo... Read More

Up to $40 Million Private Equity Financing into a New Entity Addressing Cardiac Genetic Diseases that Existing AAV Platforms are Unable to Treat Lexeo Contributing Expertise and Know-How in Cardiac Genetic Medicines, Preclinical Intellectual Property, and Technology, in Combination with Novel Non-Viral RNA Delivery Platform Represents Pipeline Diversification and Advancement of Leading-Edge Cardiovascular Science NEW YORK,... Read More

Cash runway extended into 2028; capital proceeds to fund operations through potential 2027 efficacy readout for LX2006 in Friedreich ataxia cardiomyopathy Financing led by Frazier Life Sciences and Janus Henderson Investors with participation from new and existing investors NEW YORK, May 27, 2025 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering... Read More

Announced positive interim data for LX2006 from Phase 1/2 studies in Friederich ataxia (FA) cardiomyopathy; frataxin expression and LVMI improvement exceeded co-primary target thresholds for planned registrational study LX2006 registrational study expected to begin by early 2026; commencing enrollment in prospective natural history study, CLARITY-FA, in Q2 2025 to serve as concurrent external control Phase 1/2 clinical trial... Read More

NEW YORK, May 01, 2025 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering novel treatments for cardiovascular diseases, announced today that new data supporting its AAV manufacturing approach will be presented at the 28 th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) taking place May 13-17, 2025 in New Orleans, LA. “The data... Read More

Participants with abnormal left ventricular mass index (LVMI) at baseline achieved 25% mean reduction in LVMI by 12 months or sooner Clinically meaningful improvements in majority of participants across cardiac biomarkers and functional measures All SUNRISE-FA participants achieved meaningful increases in frataxin expression at 3-months post treatment; 115% average cardiac frataxin expression increase in high dose cohort,... Read More

Additional alignment with FDA on LX2006 planned pivotal study including protein expression co-primary endpoint: based on improvements in LVMI across participants with abnormal LVMI at baseline, frataxin expression to be evaluated for any increase from baseline rather than numerical threshold Interim update from cohort 1 of LX2020 HEROIC-PKP2 Phase 1/2 trial: observed 71% and 115% increases in PKP2 protein expression in first... Read More

NEW YORK, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases, today announced that R. Nolan Townsend, Chief Executive Officer of Lexeo Therapeutics, will present at the 43 rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025 at 8:15 AM PT in San Francisco,... Read More

NEW YORK, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced that Dr. Kyle Rasbach has been appointed Chief Financial Officer, effective immediately. Dr. Rasbach brings a wealth of life sciences experience to the company... Read More

Reached alignment with FDA on key elements of registrational development plan for LX2006, including accelerated approval pathway with left-ventricular mass index (LVMI) and frataxin protein expression as co-primary registrational endpoints Received RMAT designation for LX2006 for the treatment of Friedreich ataxia (FA) cardiomyopathy, potentially enabling expedited development and increased interaction with the FDA Completed... Read More

Dose-dependent increase in neuroprotective APOE2 expression in all participants with ongoing durability at 12 months Consistent reductions across CSF tau biomarkers and tau PET in majority of participants LX1001 well tolerated across all dose cohorts with no reports of amyloid-related imaging abnormalities (ARIA) Company to host webcast today at 7:00 AM ET NEW YORK, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc.... Read More

NEW YORK, Oct. 22, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced that interim data from the ongoing Phase 1/2 trial ( NCT03634007 ) of LX1001 have been selected as a late-breaking oral presentation at the Clinical Trials on... Read More

NEW YORK, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced that Lexeo management will participate in corporate presentations and fireside chats at the following investor conferences: H.C. Wainwright 26 th Annual Global... Read More

Announced positive interim data from Phase 1/2 studies in Friedreich ataxia (FA) cardiomyopathy, which showed LX2006 was well tolerated with no treatment-related serious adverse events and demonstrated evidence of sustained and consistent treatment effect across multiple cardiac measures Recently initiated formal engagements with FDA on surrogate endpoints for LX2006 registrational study; expects to provide update by end of... Read More

Achieved mean reduction in left ventricular mass index (LVMI) of 11.4% at 12 months and 18.3% at 18 months in participants with elevated LVMI at baseline >10% reduction in LVMI at 12 months in 75% of participants with elevated LVMI at baseline Sustained and consistent improvements in other key measures of cardiac status, including left ventricular wall thickness and troponin I, in majority of participants at 12 months... Read More

NEW YORK, July 11, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced that the company will conduct an investor webcast on Monday, July 15, 2024, at 8:00 AM ET to provide an interim clinical data update on LX2006, an AAVrh10.hFXN... Read More

NEW YORK, July 08, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company, today announced the appointment of Tim Van Hauwermeiren, co-founder and Chief Executive Officer of argenx SE, as an independent, non-executive director to its Board of Directors. Mr. Van Hauwermeiren is a seasoned biotech executive with over two decades of experience in both general management and... Read More

Closed an oversubscribed $95 million equity financing in March with Q1 2024 cash balance of $195.1 million at quarter-end, expected to provide runway into 2027 Completed in-license agreement with Cornell University for intellectual property rights, including current and future clinical data from an ongoing investigator-initiated trial of AAVrh.10hFXN (LX2006) to support regulatory discussions Interim readout of combined data... Read More

NEW YORK, May 07, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc . (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced that company management will participate in fireside chats at the following investor conferences: The Citizens JMP Life Sciences Conference on Monday, May 13,... Read More

Lexeo Therapeutics gains intellectual property rights including current and future clinical data from ongoing Weill Cornell Medicine investigator-initiated trial of gene therapy candidate AAVrh.10hFXN (LX2006) to support regulatory discussions Together with Lexeo Therapeutics’ ongoing study of LX2006, a total of 11 participants have been treated to date; includes patients at treatment durations out to 18-months with no... Read More

NEW YORK, April 16, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to LX2006, the company’s AAVrh.10hFXN-based gene therapy candidate for the... Read More

NEW YORK, March 13, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced the closing of its previously announced private placement. The financing was co-led by Braidwell LP and Adage Capital Partners LP with participation from new... Read More

Lexeo announces $95.0M equity financing, which in addition to 2023 year-end cash and cash equivalents of $121.5M, extends runway to fund operations into 2027 Reports frataxin protein expression data from a subset of the second dose cohort of SUNRISE-FA, a Phase 1/2 clinical trial of LX2006 for the treatment of Friedreich’s ataxia (FA) cardiomyopathy, showing positive change in post-treatment frataxin levels Additional... Read More

NEW YORK, March 11, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced it has entered into a common stock purchase agreement with a select group of institutional and healthcare accredited investors to issue and sell an aggregate... Read More

NEW YORK, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer's disease, today announced new executive appointments to lead the evolution of the company’s pipeline into late-stage clinical development. “The accumulating talent bench at Lexeo has... Read More