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

Voyager Therapeutics (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 has cleared the Investigational New Drug 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 quoted in the press release:

“Our baculovirus manufacturing process is designed for production of AAV vectors at clinical and commercial scale, with the potential for increased yields and efficient scalability compared with mammalian-based systems,” said Bernard Ravina, M.D., M.S., chief medical officer of Voyager Therapeutics.

Click here to read the full press release.