Lexeo Therapeutics received positive FDA feedback, enabling a faster path to Accelerated Approval for LX2006 in FA cardiomyopathy. Pooled phase 1/2 interim data for LX2006 show LVMI improvements well above FDA thresholds at 6 and 12 months, supporting efficacy. LXEO maintains strong financials, with cash reserves expected to fund operations into 2028 after a recent $80 million private placement.
Lexeo Therapeutics, Inc. - Special Call Company Participants Louis Tamayo - CFO & Principal Accounting Officer R. Townsend - CEO & Director Sandi Tai - Chief Development Officer Eric Adler - Chief Medical Officer & Head of Research Conference Call Participants Tessa Romero - JPMorgan Chase & Co, Research Division Brian Skorney - Robert W.
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 ventricula...
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...
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, 2...
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 Car...
Lexeo Therapeutics Announces $80 Million Equity Financing to Further Advance Development of Transformative Genetic Medicines for Cardiovascular Diseases
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 c...
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