FDA Grants Priority Review to uniQure Huntington’s Gene Therapy
The FDA granted priority review to uniQure’s Huntington’s disease gene therapy.
Story updates
12:08:34 PM UTC
SquawkNews
FDA accepted the BLA for ifezuntirgene inilparvovec under the accelerated approval pathway and grant
12:09:35 PM UTC
SquawkNews
The FDA accepted uniQure’s BLA for investigational Huntington’s disease gene therapy ifezuntirgene inilparvovec and granted Priority Review, setting a May 1, 2027 PDUFA target date. The FDA is tentatively planning an advisory committee discussion.Material DetailsContext by AI AnalystThis is a late…
12:23:27 PM UTC
SquawkNews
uniQure said the FDA accepted its Huntington’s disease gene therapy application for Priority Review, with a target decision date of May 1, 2027.Key Highlights:Original SEC Filing: uniQure N.V. [ QURE ] - 8-K - Nov. 02, 2026This is an AI-powered summary. It may contain inaccuracies. Consider verifyi…