FDA says Voyager can trek on as it removes trial hold for Huntington's gene therapy test

Submitted by admin on April 26, 2021 - 11:14am

Source:

Fierce Biotech

News Tags:

FDA

Voyager Therapeutics

VY-HTT01

gene therapy

Huntington's disease

Headline:

FDA says Voyager can trek on as it removes trial hold for Huntington's gene therapy test

snippet:

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.

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FDA says Voyager can trek on as it removes trial hold for Huntington's gene therapy test

FDA says Voyager can trek on as it removes trial hold for Huntington's gene therapy test