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Voyager Therapeutics Announces FDA Clearance of Investigational New Drug Application for VY-AADC for Advanced Parkinson’s Disease

VOYAGER THERAPEUTICS (VYGR)  More Company Research Source: GlobeNewswire
Last voyager therapeutics earnings: 8/8 07:05 am Check Earnings Report
US:NASDAQ Investor Relations: ir.voyagertherapeutics.com
PDF CAMBRIDGE, Mass., Jan. 23, 2018 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ:VYGR), a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for VY-AADC, allowing the Company to formally initiate clinical trial sites, screen and begin dosing patients for its pivotal Phase 2-3 program for advanced Parkinson’s disease. As part of this IND, the chemistry, manufacturing, and controls section included data demonstrating comparability between VY-AADC produced under good manufacturing practice (GMP) using Voyager’s baculovirus/Sf9 manufacturing process and VY-AADC produced using a mammalian cell system consisting of triple-transfection of human embryonic kidney (HEK293) cells.  “Our baculovirus manufacturing process is designed for production of AAV vectors at clinical and commercial scale, with t [Read more]

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