Wall Street Has a Positive Outlook on uniQure N.V. (QURE) Despite Challenges From The FDA

​uniQure N.V. (NASDAQ:QURE) is one of the Hottest Small Cap Stocks to Buy Now. Wall Street has a positive outlook on uniQure N.V. (NASDAQ:QURE) despite the regulatory challenges from the FDA for its experimental gene therapy called AMT-130. On November 12, Yanan Zhu from Wells Fargo also reiterated a Buy rating on uniQure N.V. (NASDAQ:QURE), but lowered the price target from $80 to $60. A day earlier, TD Cowen analyst Joseph Thome had maintained a Buy rating on the stock without disclosing any price target.

​Earlier in September, uniQure N.V. (NASDAQ:QURE) presented critical results from a three-year study of their experimental gene therapy called AMT-130, aimed at treating Huntington’s disease. The results showed a significant reduction in disease progression.

​However, regardless of the encouraging results, the FDA on November 3 provided negative feedback for AMT-130. As per the management, the FDA no longer thinks the data from their early Phase I/II studies of AMT-130 is enough to support their main evidence for getting approval to sell the therapy. As a result, the timing for the pre-Biologics License Application for AMT-130 is now unclear.

​Analyst Joseph Thome from TD Cowen noted that management’s confidence in the data and potential of AMT-130 remains robust. He mentioned the company is in active engagement with the FDA to explore a viable way forward. Thome remains confident in the company’s ability to address these concerns effectively.

uniQure N.V. (NASDAQ:QURE) is a biotechnology company based in the Netherlands that develops gene therapies designed to be given once and potentially cure severe genetic diseases.

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Disclosure: None. This article is originally published at Insider Monkey.