FDA accepts and grants priority review to uniQure's gene therapy BLA for Huntington’s disease with decision by May 2027

The FDA has accepted uniQure's Biologics License Application (BLA) for ifezuntirgene inilparvovec, a gene therapy for Huntington’s disease, and granted it Priority Review with a target decision date of May 1, 2027. If approved, it would be the first disease-modifying treatment for this rare neurodegenerative disorder. The approval process includes a planned advisory committee meeting, and uniQure is preparing a confirmatory Phase III trial with patient screening expected to start by the end of 2026. This therapy has previously received Breakthrough Therapy, RMAT, and Fast Track designations from the FDA, reflecting its potential significance.

Following the FDA's acceptance and priority review of uniQure's gene therapy application for Huntington’s disease, uniQure's shares have seen notable activity. On Pluang, QURE trades at USD 26.27, up 5.80% as of Nov 02, 2026 19:21 WIB, reflecting increased investor attention. The stock holds a market cap of $1.72 billion with a 52-week range between $9.03 and $67.69, and typical holding time on Pluang is 9 days.