This is the second clinical hold in as many months for Cambridge, Mass.-based Voyager. In October, the
FDA placed a clinical hold on the company’s Huntington’s disease gene therapy before that asset could make its way into the clinic.
Late Tuesday, Voyager announced the latest hold. The FDA placed a hold on the RESTORE-1 clinical trial of NBIb-1817 (VY-AADC) after partner Neurocrine Biosciences submitted an Investigational New Drug Safety Report related to the observation of MRI abnormalities in some RESTORE-1 study participants. The clinical implications of this observation are currently unknown and are being evaluated, Voyager said in its announcement.