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Positive Outlook for uniQure’s AMT-130 Program Drives Buy Rating Amid Regulatory Advancements and Robust Clinical Framework

Positive Outlook for uniQure’s AMT-130 Program Drives Buy Rating Amid Regulatory Advancements and Robust Clinical Framework

Stifel Nicolaus analyst Paul Matteis has maintained their bullish stance on QURE stock, giving a Buy rating yesterday.

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Paul Matteis has given his Buy rating due to a combination of factors surrounding uniQure’s recent advancements with their AMT-130 program for Huntington’s disease. The company has achieved alignment with the FDA on manufacturing and a three-year data analysis plan, which is expected to lead to a Biologics License Application filing in the first quarter of 2026. This development follows a favorable dialogue with the FDA and the receipt of a Regenerative Medicine Advanced Therapy designation, indicating strong regulatory support.
Moreover, the use of the ENROLL-HD study, the largest natural history study for Huntington’s disease, as a control for the AMT-130 clinical data, provides a robust framework for assessing the treatment’s efficacy. The lower attrition rates and extended follow-up in ENROLL-HD enhance the reliability of the data, addressing concerns about inflated outcomes due to dropouts in previous studies. These strategic decisions by uniQure, along with the potential for accelerated approval, underpin the positive outlook and Buy rating from Paul Matteis.

In another report released yesterday, Wells Fargo also maintained a Buy rating on the stock with a $30.00 price target.

QURE’s price has also changed dramatically for the past six months – from $7.130 to $14.485, which is a 103.16% increase.

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