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Voyager Therapeutics (NASDAQ:VYGR) - Voyager CEO Resigns After Company Turns Back To Discovery-Stage

Voyager Therapeutics, Inc (NASDAQ: VYGR) CEO and President Andre Turenne will step down as the beleaguered company announced it would move . ....

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iShares NASDAQ Biotechnology Index Fund (NASDAQ:IBB), Adaptimmune Therapeutics PLC (NYSE:ADAP) - The Daily Biotech Pulse: Pfizer-BioNTech COVID-19 Order Flow Abounds, Voyager CEO, CMO To Depart, Decision Day For Bristol-Myers Squibb, ASCO Abstracts Move Stocks

iShares NASDAQ Biotechnology Index Fund (NASDAQ:IBB), Adaptimmune Therapeutics PLC (NYSE:ADAP) - The Daily Biotech Pulse: Pfizer-BioNTech COVID-19 Order Flow Abounds, Voyager CEO, CMO To Depart, Decision Day For Bristol-Myers Squibb, ASCO Abstracts Move Stocks
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FDA says Voyager can trek on as it removes trial hold for Huntington's gene therapy test

(Jensflorian CC BY-SA 3.0)
The FDA is in a forgiving mood: After clearing uniQure’s gene therapy to restart trials today, it’s handing the same reprieve to Voyager Therapeutics.
The biotech was slapped with a clinical hold on an IND for the program, VY-HTT01, because of issues with chemistry, manufacturing and controls (CMC). This marked a miserable time for the program, coming one year after Sanofi’s Genzyme unit pulled out of a collab for it.
But now the FDA has lifted its hold on the gene therapy candidate in Huntington’s disease (HD), and “confirmed that the company may proceed with its planned phase 1/2 clinical trial,” according to a statement from the company, which plots to start this year in early HD patients. ....

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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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10 Figures In Biotech Revolutionizing Treatment Of Neurological Disorders

10 Figures In Biotech Revolutionizing Treatment Of Neurological Disorders
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