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Investing.com - H.C. Wainwright lowered its price target on uniQure BV (NASDAQ:QURE) to $70 from $110 while maintaining a Buy rating following a regulatory setback for the company’s Huntington’s disease treatment. Despite the reduced target, this still represents significant upside from the current price of $34.29.
The firm’s adjustment comes after uniQure announced that the FDA indicated data from its single-arm Phase 1/2 AMT-130 program may no longer be sufficient as primary evidence for a Biologics License Application (BLA) in Huntington’s disease.
The FDA’s position represents a significant change from uniQure’s previous plans, forcing the company to withdraw its prior guidance that called for BLA submission in the first quarter of 2026.
H.C. Wainwright noted that despite this setback, which it does not view as being data-driven, the firm remains confident that a viable regulatory path should emerge based on AMT-130’s data in Huntington’s disease and uniQure’s execution track record.
The stock experienced a sharp sell-off of approximately 50% on Monday, November 3, compared to a 2% decline in the XBI biotech index, which H.C. Wainwright believes overstates the fundamental impact of the regulatory delay. According to InvestingPro data, the stock is now trading below its Fair Value, despite the company’s 516% return over the past year. InvestingPro analysis shows that 7 analysts have recently revised their earnings upwards for the upcoming period, suggesting continued confidence in the company’s prospects despite this setback. Subscribers to InvestingPro can access 15 additional insights and detailed financial metrics to better evaluate uniQure’s position following this significant price movement.
In other recent news, uniQure N.V. faced a significant regulatory challenge as the U.S. Food and Drug Administration (FDA) reversed its stance on the company’s Huntington’s disease treatment candidate, AMT-130. The FDA’s decision indicates that data from Phase I/II studies will not suffice for a Biologics License Application submission, marking a departure from previous communications. Despite this setback, H.C. Wainwright has maintained its Buy rating on uniQure and raised the stock’s price target from $70 to $110, following positive three-year results from pivotal Phase 1/2 trials. Additionally, uniQure successfully completed a public offering, raising approximately $345 million in gross proceeds to support its gene therapy pipeline. The offering included 6,736,841 ordinary shares sold at $47.50 each, along with pre-funded warrants for certain investors. Prior to this, the company had announced the pricing of a $300 million public offering, consisting of 5,789,473 ordinary shares and pre-funded warrants. These developments come as uniQure continues to navigate the complex landscape of gene therapy advancements and regulatory approvals.
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