UniQure (QURE) stock plummeted on Monday after the U.S. Food and Drug Administration (FDA) backtracked on plans to support the company’s filing of a Biologics License Application (BLA) for AMT-130. This is an investigational gene therapy designed to treat patients suffering from Huntington’s disease, a progressive, inherited neurodegenerative disorder that affects movement, cognition, and behavior.
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According to UniQure, the final minutes from the meeting aren’t available yet, but the company believes the FDA no longer agrees that the data provided in its Phase I/II studies of AMT-130 are sufficient for a BLA application. This comes after roughly a year of meetings with the FDA, in which UniQure was led to believe that the regulator would support a BLA for AMT-130. This change also comes despite UniQure being granted Breakthrough Therapy designation for AMT-130 by the FDA earlier this year.
Matt Kapusta, CEO of UniQure, said, “This news is unexpected, and we are truly disappointed for people living with HD, who have no disease-modifying treatment options for this devastating disease. We strongly believe that AMT-130 has the potential to bring substantial benefit to patients, and we remain fully committed to working with the FDA to determine the best path forward to rapidly bring AMT-130 to patients and their families in the U.S.”
UniQure Stock Movement Today
UniQure stock was down 58% on Monday morning but remained up 283.3% year-to-date. The stock has also rallied 1,117.45% over the past 12 months.
Today’s news has also resulted in heavy trading of QURE stock. As of this writing, more than 6.23 million shares have changed hands, compared to a three-month daily average of about 5.71 million units.
Is UniQure Stock a Buy, Sell, or Hold?
Turning to Wall Street, the analysts’ consensus rating for UniQure is Strong Buy, based on 11 Buy and a single Hold rating over the past three months. With that comes an average QURE stock price target of $75.50, representing a potential 166.03% upside for the shares. However, these ratings and price targets could change in light of today’s FDA update.
