FDA grants priority review to uniQure's Huntington's gene therapy
QURE•The FDA accepted uniQure's application for ifezuntirgene inilparvovec, granting priority review and setting a May 1, 2027, target decision date under the accelerated approval pathway.
1. Priority review granted
The FDA accepted uniQure's approval application for its Huntington's disease gene therapy, ifezuntirgene inilparvovec, and granted it priority review. The agency set May 1, 2027, as its target decision date under the accelerated approval pathway.
