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tz-plus logo uniQure: From FDA Shock to Mega Comeback? - The Billion-Dollar Gamble on the Gene Therapy Breakthrough Convincing Wells Fargo Experts

M. Herzberger
Reading Time: 3 minutes

Regulatory Disturbance and Perspective In early March 2026, shareholders of uniQure N.V. (QURE) experienced an unprecedented rollercoaster ride closely linked to the regulatory hurdles for the Huntington gene therapy AMT-130. Initially, the stock plummeted nearly 40% following critical feedback from the US health authority FDA, as the agency unexpectedly demanded a randomized, placebo-controlled sham surgery study and deemed the existing Phase I/II data insufficient compared to historical disease trajectories. From the company's perspective,...

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