Unicure ($QURE) Granted FDA Priority Review; Target Review Date May 2027

uniQure's Huntington's disease gene therapy candidate AMT-130 (epedutirgene inolparvovec) has been accepted for filing and granted Priority Review by the FDA, with a target action date of May 1, 2027. The company submitted a Biologics License Application (BLA) seeking accelerated approval based on the therapy's ability to slow the progression of Huntington's disease. Priority Review means the FDA will review the application on a shortened timeline, though the agency notes the designation does not alter the scientific or medical standards required for approval. The decision marks a key regulatory milestone for the first gene therapy candidate for Huntington's disease, a fatal neurodegenerative disorder with limited treatment options. Investors will be watching for an FDA advisory committee meeting, any clinical hold or information requests, and the final approval decision ahead of the 2027 action date.