UniQure to file for FDA approval of Huntington’s gene therapy in the third quarter after agency reversal

UniQure said it plans to seek FDA approval for its experimental gene therapy for Huntington’s disease in the third quarter of this year. The move follows a recent FDA meeting in which the agency said a three-year analysis from a Phase 1/2 study could support accelerated approval. The announcement comes months after UniQure was drawn into a public dispute with FDA leaders over whether its clinical trial data were sufficient.