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NASDAQ:QURE 24 September 2025 - 18 June 2026

uniQure Gets Go-Ahead From FDA for AMT-130 Huntington’s Gene Therapy Application

uniQure Gets Go-Ahead From FDA for AMT-130 Huntington’s Gene Therapy Application

uniQure said Wednesday the U.S. Food and Drug Administration will let it use three-year data from its early Huntington’s gene therapy trial as the basis for an accelerated approval filing, changing course in the dragged-out regulatory battle over the therapy. The company will go ahead with a biologics license application in the third quarter. That application is the standard FDA process for marketing a biologic drug in the U.S.
17 June 2026
uniQure (QURE) Stock Jumps in Pre-Market on Dec. 16, 2025: FDA AMT-130 Uncertainty, Analyst Price Targets, and Key Catalysts Ahead

uniQure (QURE) Stock Jumps in Pre-Market on Dec. 16, 2025: FDA AMT-130 Uncertainty, Analyst Price Targets, and Key Catalysts Ahead

Dec. 16, 2025 — uniQure N.V. is back in the spotlight Tuesday after a notable extended-hours rebound. The gene therapy developer’s shares were highlighted among top pre-market gainers, rising about 15% to roughly $23.50 in early trading, following a strong after-hours move the prior session. StockAnalysis+1
UniQure’s Roller-Coaster: Gene Therapy Breakthrough, FDA Setback, and What’s Next for QURE Stock

UniQure’s Roller-Coaster: Gene Therapy Breakthrough, FDA Setback, and What’s Next for QURE Stock

UniQure’s stock has been on a wild ride in 2025. After starting the year in the mid-teens, QURE shares skyrocketed through mid-2025 on hopes for its Huntington’s gene therapy. The rally hit a fever pitch in late September when Phase 1/2 trial data showed a remarkable 75% reduction in disease progression with AMT-130 – news that caused the stock to surge almost 200% that monthreuters.com. By late October, QURE was hovering around $68–$70, up roughly 300–500% from spring levels.
uniQure (QURE) Stock Soars on Huntington’s Breakthrough – Key Facts & 2025 Outlook

Gene Therapy Breakthrough: uniQure’s QURE Stock Skyrockets on Huntington’s Triumph

uniQure’s stock performance in 2025 has been remarkably strong, capped by the explosive move on Sep. 24 after the Huntington’s data release. Prior to the announcement, QURE was trading in the mid-teens ts2.tech – already up over 100% year-to-date as anticipation for the trial results built. When the pivotal results hit, trading was halted pre-market due to pending news ts2.tech. Once the halt lifted, the stock opened dramatically higher and at one point reached the mid-$40s per share, up nearly 160–200% in a single session pharmaphorum.com. It eventually closed with a gain of around 150%+ on the day investing.com. This massive one-day jump is one of the biotech sector’s biggest of 2025, reflecting how transformational the news was for uniQure’s outlook.
uniQure (QURE) Stock Soars on Huntington’s Breakthrough – Key Facts & 2025 Outlook

uniQure (QURE) Stock Soars on Huntington’s Breakthrough – Key Facts & 2025 Outlook

Historic Huntington’s Results: On September 24, 2025, uniQure revealed landmark Phase I/II trial results for its Huntington’s disease gene therapy AMT-130. In patients treated with a one-time injection of AMT-130, disease progression was significantly slowed – by about 75% over three years for those on the high dose reuters.com. Treated patients maintained far more of their motor and cognitive function compared to the expected decline in Huntington’s, which is an invariably progressive and fatal neurodegenerative disorder reuters.com reuters.com. Crucially, there are currently no approved drugs that slow Huntington’s disease, so these results position AMT-130 as potentially the first disease-modifying therapy in this space reuters.com.