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Voyager Therapeutics Receives FDA Clearance of IND Application for Gene Therapy Candidate VY-HTT01 for Treatment of Huntington's Disease


Published: Apr 26, 2021
Initiation of VYTAL Phase 1/2 Clinical Trial at Multiple Sites Expected this Year
CAMBRIDGE, Mass., April 26, 2021 (GLOBE NEWSWIRE) 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. ....

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