uniQure NV (QURE) — Research Summary as of August 28, 2026

The Core Catalyst Behind the Move

The primary driver of QURE's dramatic move has been a reversal by the FDA regarding the BLA (Biologics License Application) pathway for AMT-130, uniQure's gene therapy for Huntington's disease. According to [2] and [3], the FDA reopened the AMT-130 BLA path, which was described as "a stark reversal from late 2025 and early 2026, when the FDA expressed skepticism regarding the reliance on external [data]" [3]. This news broke around June 17, 2026, and shares surged approximately 78.44% on that day alone [5]. The Wall Street Journal covered the story under the headline "uniQure Shares Surge After FDA's Reversal on Gene Therapy" [5].