Key update sent Voyager Therapeutics (VYGR) stock go bullish in the After-hours

GILD Stock
GILD Stock

Voyager Therapeutics (Nasdaq: VYGR) shares dropped -14.73% to $7.7 in the After-market ‎session on Tuesday after the U.S. Neurocrine Biosciences (Nasdaq: NBIX) has been told by ‎the Food and Drug Administration (FDA) that it has put a clinical hold on the NBIb-1817b ‎clinical trial RESTORE-1 (VY-AADC). It was previously disclosed that sites participating in ‎RESTORE-1 had not been screening, enrolling, or dosing patients due to the ongoing COVID-‎‎19 pandemic and more recently, the independent Data Safety Monitoring Board’s request to ‎pause the study in order to collect additional data. The DSMB sought further patient level ‎data from the study and is now preparing to revisit this data at the beginning of 2021. The ‎clinical retention follows the submission of an IND Safety Report by Neurocrine Biosciences ‎pertaining to the observation of MRI anomalies in certain members of the RESTORE-1 trial. ‎At present, the clinical effects of this finding are uncertain and are being assessed.‎

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‎RESTORE-1 is a phase 2 clinical trial of the intracerebral AAV-based investigational gene ‎therapy NBIb-1817 (VY-AADC) in progress for Parkinson’s disease treatment. As well as the ‎research investigators and national and local ethics boards, the RESTORE-1 DSMB was told ‎of the therapeutic keeping. In order to define the next steps for the RESTORE-1 clinical trial, ‎Neurocrine Biosciences and Voyager will collaborate closely with the FDA and the DSMB.‎

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