Voyager Therapeutics Gets FDA OK of IND for Huntington's Gene Therapy

 Voyager Therapeutics, Inc. (Nasdaq: VYGR), a clinical-stage gene therapy company developing life-changing treatments for severe neurological diseases, today announced the U.S. Food and Drug Administration (FDA) has removed its clinical hold on the company’s Investigational New Drug (IND) application for VY-HTT01, a gene therapy candidate for the treatment of Huntington’s disease (HD), and confirmed that the company may proceed with its planned Phase 1/2 clinical trial. The decision was made following a comprehensive review of the Chemistry, Manufacturing and Controls information previously submitted to the FDA. Voyager plans to initiate VYTAL, a Phase 1/2 clinical trial of VY-HTT01, this year.

https://www.biospace.com/article/releases/voyager-therapeutics-receives-fda-clearance-of-ind-application-for-gene-therapy-candidate-vy-htt01-for-treatment-of-huntington-s-disease/