LONDON, UK / ACCESSWIRE / January 25, 2018 / Active-Investors.com has just released a free research report on Voyager Therapeutics, Inc. (NASDAQ: VYGR). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=VYGR as the Company's latest news hit the wire. On January 23, 2018, the Company announced that the US Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for VY-AADC, allowing the Company to initiate clinical trial sites, screen and begin dosing patients for its pivotal Phase 2-3 program for advanced Parkinson's disease. Register today and get access to over 1,000 Free Research Reports by joining our site below:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Voyager Therapeutics most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

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Baculovirus Manufacturing Process is Designed for Production of AAV Vectors at Clinical and Commercial Scale

As part of the 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 using a mammalian cell system consisting of triple-transfection of human embryonic kidney (HEK293) cells. The baculovirus manufacturing process is designed for production of AAV (adeno-associated virus) vectors at clinical and commercial scale, with the potential for increased yields, and efficient scalability compared with mammalian-based systems.

Voyager Plans to Dose the First Patient During Q2 2018

Bernard Ravina, M.D., M.S., Chief Medical Officer of Voyager Therapeutics, stated that having demonstrated comparability between the baculovirus and mammalian-based VY-AADC, the Company has initiated its pivotal program and begin dosing patients with the baculovirus-produced vector. Bernard added that following institutional review board approval and patient screening at clinical referral and surgical sites, Voyager continues to plan to dose the first patient in its pivotal program during the second quarter of this year.

Voyager Announced Positive Results from Phase-1b Trial of VY-AADC01 in September 2017

On September 06, 2017, Voyager announced positive results from its ongoing Phase-1b trial of VY-AADC01 in advanced Parkinson's disease. The results demonstrated durable, dose-dependent, and time-dependent improvements across multiple measures of patients' motor function after a one-time administration of the gene therapy. In the Phase-1b, open-label trial, 15 patients with advanced Parkinson's disease and disabling motor fluctuations were treated with a single administration of VY-AADC01. The Company planned to begin the global, pivotal Phase 2-3 program for VY-AADC at the end of 2017.

Drugs Therapy Approved by FDA in 2017 for Treatment of Parkinson's Disease

  • In March 2017, FDA approved the use of Newron Pharmaceuticals' Xadago® (safinamide) for the treatment of Parkinson's disease as add-on therapy to levodopa/carbidopa.

  • In August 2017, FDA approved Adamas Pharmaceuticals' GOCOVRI (amantadine) extended release capsules (previously ADS-5102) for treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI, previously granted orphan drug status by the FDA, is the first and only medicine approved by the FDA for this indication.

What is Parkinson's Disease?

Parkinson's disease is a neurodegenerative disorder which leads to progressive deterioration of motor function due to loss of dopamine-producing brain cells. The cause of the disease is unknown. Most individuals with Parkinson's disease are diagnosed when they are 60 years old or older, but early-onset Parkinson's disease also occurs. Several staging systems for this disease exist depending upon the organization that treats and researches the disease. Stage 5 is the most advanced stage of Parkinson's disease. Symptoms during the advanced stages of the disease include falling, gait freezing, and difficulty with speech and swallowing, with patients often requiring the daily assistance of a caregiver.

About VY-AADC

VY-AADC, comprised of the adeno-associated virus-2 capsid and a cytomegalovirus promoter to drive aromatic L-amino acid decarboxylase (AADC) transgene expression, is designed to deliver the AADC gene directly into neurons of the putamen where dopamine receptors are located, bypassing the substantia nigra neurons and enabling the neurons of the putamen to express the AADC enzyme to convert levodopa into dopamine. The approach with VY-AADC, therefore, has the potential to durably enhance the conversion of levodopa to dopamine and provide clinically meaningful improvements by restoring motor function in patients and improving symptoms following a single administration.

About Voyager Therapeutics, Inc.

Founded in 2013, Voyager Therapeutics is a gene therapy company developing life-changing treatments for severe neurological diseases. Voyager Therapeutics is committed to advancing the field of AAV gene therapy through innovation and investment in vector optimization and engineering, dosing techniques as well as process development and production. The Company is headquartered in Cambridge, Massachusetts.

Stock Performance Snapshot

January 24, 2018 - At Wednesday's closing bell, Voyager Therapeutics' stock marginally declined 0.81%, ending the trading session at $20.90.

Volume traded for the day: 277.28 thousand shares.

Stock performance in the last month ? up 34.15%; previous six-month period ? up 120.23%; past twelve-month period ? up 81.58%; and year-to-date - up 25.90%

After yesterday's close, Voyager Therapeutics' market cap was at $558.66 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.3% at the end of the session.

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