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Investing.com - Stifel has reiterated its Buy rating and $30.00 price target on uniQure BV (NASDAQ:QURE), currently trading at $13.66, following the release of three-year data for its AMT-130 treatment in Huntington’s Disease. The stock has shown remarkable resilience with a 165% return over the past year, though InvestingPro analysis suggests current valuation is near Fair Value.
The three-year data exceeded expectations, showing a 75% disease-slowing effect on the composite Unified Huntington’s Disease Rating Scale (cUHDRS) compared to natural history, with statistical significance (p=0.003).
The treatment demonstrated a statistically significant benefit on Total Functional Capacity (TFC) with p=0.033, which Stifel noted was an upside surprise that could be important to FDA approval considerations.
AMT-130 also showed efficacy across various other sub-scales and maintained three-year neurofilament/NfL levels below baseline, further supporting the treatment’s potential effectiveness.
Stifel believes these results strengthen uniQure’s prospects for accelerated FDA approval, with the company on track for a Biologics License Application (BLA) submission in the first quarter of 2026, though the firm acknowledged some limitations including small sample size and reliance on natural history comparison.
In other recent news, uniQure N.V. has secured a $175 million non-dilutive senior secured term loan facility with Hercules Capital. This agreement enhances uniQure’s financial flexibility, particularly for the potential commercial launch of its gene therapy, AMT-130, aimed at treating Huntington’s disease. The loan facility refinances an existing $50 million debt, extending its term to October 2030, and provides access to an additional $125 million under specific conditions. On the analyst front, Cantor Fitzgerald has reiterated an Overweight rating on uniQure, with a price target of $47.00, citing the potential of AMT-130. Mizuho also maintains its Outperform rating and a $30.00 price target, viewing the recent stock price drop as a buying opportunity. Furthermore, H.C. Wainwright continues to support uniQure with a Buy rating and a $70.00 price target, following promising initial Phase 1/2a data for its Fabry disease gene therapy, AMT-191. The data showed significant enzyme activity increases and a manageable safety profile. These developments underscore uniQure’s ongoing efforts in advancing its therapeutic pipeline.
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