Business
Voyager Therapeutics Announces Fourth Quarter and Full Year 2020 Financial Results and Corporate Updates
Expects to Provide Complete Response to FDA Requests on IND Application for VY-HTT01 for Huntington’s Disease in the First Half of 2021Continues to Progress
About this update from Voyager Therapeutics, Inc.
[{"type":"text","content":"Expects to Provide Complete Response to FDA Requests on IND Application for VY-HTT01 for Huntington’s Disease in the First Half of 2021Continues to Progress Pipeline and Platform Activities with Expected Presentations of Data in the First Half of 2021 CAMBRIDGE, Mass., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ: VYGR), a clinical-stage gene therapy company focused on developing life-changing treatments for patients suffering from severe neurological diseases, today reported its fourth quarter and full year 2020 financial results and provided corporate updates. “We have made significant progress readying our lead wholly owned program, VY-HTT01 for Huntington’s disease, for clinical trials,” said Andre Turenne, President and CEO of Voyager. “We have also continued to advance our preclinical portfolio, including our innovative vectorized antibodies, and have achieved highly promising results with our TRACER platform to identify viral capsids that can cross the blood-brain barrier. With these developments, we look forward to initiating a new phase in our mission to deliver transformative therapies for those affected with severe neurological diseases.” Recent Corporate Updates The Investigational New Drug (IND) application for VY-HTT01 for the treatment of Huntington’s disease remains on clinical hold by the U.S. Food and Drug Administration (FDA) pending the resolution of additional information requests regarding specific chemistry, manufacturing and controls (CMC) topics, including drug device compatibility and drug substance and product characterization. Voyager plans to provide its complete response to the FDA in the first half of 2021 and to initiate its clinical evaluation of VY-HTT01 subject to and upon resolution of the clinical hold and the clearance of the IND application.In December 2020, Voyager published a peer-reviewed manuscript in Molecular Therapy Methods & Clinical Development entitled “Rapid Evolution of Blood-Brain Barrier-Penetrating AAV Capsids by RNA-Driven Biopanning” which describes the foundational proof-of-concept experiments for Voyager’s proprietary TRACER™ platform. Voyager is leveraging the TRACER platform to facilitate the selection of AAV capsids with significantly improved blood-brain barrier crossing and cell-specific transduction properties for therapeutic applications.The...