QURE Rises Following FDA Support for Accelerated Approval of AMT-130 Data

uniQure (QURE) shares surged 78.4% on June 17, 2026, following the announcement of a significant regulatory advancement for AMT-130, an investigational gene therapy for Huntington’s disease. The FDA indicated that three-year data from a Phase I/II study could be used as the primary basis for a biologics license application (BLA) seeking accelerated approval. However, shares dipped 3.9% the following day.

The FDA’s type B meeting with uniQure, which concluded recently, established that alignments on the confirmatory study design are necessary before the BLA submission, projected for the third quarter of 2026. The FDA has committed to working expeditiously with uniQure to finalize these plans. AMT-130, currently evaluated in two ongoing multi-center, dose-escalating studies, aims to treat Huntington’s disease and has received multiple FDA designations, including Regenerative Medicine Advanced Therapy.

In total, the U.S. Phase I/II study included 26 patients, while a European study involved 13 patients. Historically, QURE shares have increased 93.4% in the current year, contrasting sharply with the industry’s 1.8% decline.