LX2006 gene therapy now on FDA fast track for heart disease in FA

The U.S. Food and Drug Administration (FDA) has put Lexeo Therapeutics’ LX2006, a gene therapy candidate for heart disease in people with Friedreich’s ataxia (FA), on the fast track for development. The award of fast track status aims to expedite the development and regulatory review of investigational therapies…

FDA Clears Phase 1/2 Trial of Gene Therapy for FA Heart Disease

The U.S. Food and Drug Administration (FDA) has approved a Phase 1/2 clinical trial for LX2006, Lexeo Therapeutics’ investigational gene therapy for heart disease in people with Friedreich’s ataxia (FA). Lexeo submitted the trial for approval under an investigational new drug (IND) application based on promising preclinical data. The…

Potential Gene Therapy for Heart Disease in FA Gets FDA Support

The U.S. Food and Drug Administration (FDA) has given rare pediatric disease and orphan drug designations to LX2006, Lexeo Therapeutics‘ investigational gene therapy for people with Friedreich’s ataxia (FA). The designations each provide benefits meant to ease the therapy’s path through development. Rare pediatric disease status is provided to…

Lexeo Licenses Rights to Potential Gene Therapy LX2006

Lexeo Therapeutics has entered an agreement with Adverum Biotechnologies to license Adverum’s intellectual property rights and pre-clinical data of LX2006, an investigational gene therapy for Friedreich’s ataxia (FA). Lexeo will continue to advance the gene therapy program through pre-clinical studies that support an investigational new drug (IND) application,…

Startup Lexeo Raises $85M to Pursue 3 New Gene Therapies

Lexeo Therapeutics recently launched with an initial funding of $85 million to develop gene therapies for Friedreich’s ataxia (FA) and other disorders. The proceeds will support the clinical development of three gene therapy programs, including an anticipated Phase 1 trial this year to test LX2006 for FA-associated heart…