FDA slaps a hold on Voy­ager's lead gene ther­a­py over 'M­RI ab­nor­mal­i­ties'

A rocky year for gene ther­a­py is clos­ing out with more bleak news.

Voy­ager Ther­a­peu­tics an­nounced Tues­day that the FDA has forced the com­pa­ny to halt stud­ies on their lead pro­gram, a gene ther­a­py for Parkin­son’s dis­ease, af­ter “MRI ab­nor­mal­i­ties” ap­peared in some pa­tients in a Phase II tri­al. The hold comes a month af­ter Voy­ager dis­closed that a da­ta safe­ty mon­i­tor­ing board had rec­om­mend­ed a pause af­ter “re­view[ing] cer­tain pa­tient imag­ing da­ta.”

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