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uniQure ( (QURE) ) has issued an announcement.
On April 30, 2026, uniQure announced it had held a successful pre-submission meeting with the UK Medicines and Healthcare products Regulatory Agency regarding AMT-130, its investigational gene therapy for Huntington’s disease, and plans to file a UK Marketing Authorization Application in the third quarter of 2026. The company intends to base the filing on three-year Phase I/II data showing a statistically significant 75% slowing of disease progression at the high dose versus an external control, while it also prepares for a Type B meeting with the U.S. FDA on a potential Phase III design and actively pursues additional international regulatory pathways, underscoring a pivotal phase in AMT-130’s global registration strategy and potential future market entry.
uniQure is positioning AMT-130 for potential UK approval in 2026, supported by three-year Phase I/II data indicating a 75% slowing of disease progression at high dose.
The company is engaging the U.S. FDA on Phase III design and pursuing additional ex-US regulatory routes, signaling a coordinated push toward global registration of AMT-130 for Huntington’s disease.
The most recent analyst rating on (QURE) stock is a Buy with a $70.00 price target. To see the full list of analyst forecasts on uniQure stock, see the QURE Stock Forecast page.
Spark’s Take on QURE Stock
According to Spark, TipRanks’ AI Analyst, QURE is a Neutral.
The score is held down primarily by weak financial performance (persistent losses and cash burn) and a bearish technical setup (below key moving averages, negative MACD). The earnings call provides some offset via strong clinical efficacy signals and improved liquidity, but the FDA’s Phase III requirement and program safety pauses materially raise execution and timeline risk; valuation remains difficult to support with negative earnings and no dividend.
To see Spark’s full report on QURE stock, click here.
More about uniQure
uniQure N.V., listed on Nasdaq as QURE, is a gene therapy company focused on single-treatment, potentially curative therapies for severe diseases. The company has already achieved regulatory approvals for its hemophilia B gene therapy and is advancing a pipeline targeting Huntington’s disease, refractory temporal lobe epilepsy, Fabry disease and other serious conditions.
Average Trading Volume: 3,178,692
Technical Sentiment Signal: Sell
Current Market Cap: $1.03B
For detailed information about QURE stock, go to TipRanks’ Stock Analysis page.