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Shares of uniQure BV (NASDAQ:QURE), which has seen a remarkable 175% return over the past year, are in focus following the reaffirmation of a Buy rating and a $70.00 price target by H.C. Wainwright. According to InvestingPro data, analyst targets range from $13.24 to $70.25, with the stock currently trading around $13.29. The endorsement comes after uniQure announced on April 17 that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to its leading gene therapy program, AMT-130, for the treatment of Huntington’s disease (HD).
The Breakthrough Therapy designation is seen as a positive step toward the regulatory interactions expected in the second quarter of 2025, and the upcoming data readouts from the AMT-130 Phase 1/2 trials anticipated in the third quarter of 2025. This progress is viewed as a precursor to a potential Biologics License Application (BLA) filing for AMT-130 in HD.
H.C. Wainwright analysts have highlighted the designation as supporting an accelerated approval pathway, suggesting a possible commercial launch of the treatment in 2026. The firm’s confidence in uniQure is further bolstered by the company’s strong financial position, with sufficient cash to fund operations into the second half of 2027. InvestingPro analysis confirms the company’s solid liquidity position with a current ratio of 9.74, though it flags that the company is quickly burning through cash. Get access to 8 more exclusive InvestingPro Tips to better understand uniQure’s financial health.
The pipeline of gene therapies under development by uniQure, alongside the high probability of success in treating Huntington’s disease, has led analysts to consider the stock significantly undervalued. With multiple clinical data readouts expected in the years 2025-2026, there is anticipation for the company’s continued progress.
Reflecting on the recent developments and the potential for uniQure’s gene therapy program, H.C. Wainwright analysts maintain a bullish stance on the stock, reiterating their $70 price target. The firm’s analysts see the Breakthrough Therapy designation as an important milestone for uniQure, underscoring the momentum of its gene therapy pipeline and the prospects for its lead program, AMT-130. The company’s market capitalization stands at $719 million, with revenue growing 71% in the last twelve months, though InvestingPro data indicates the company is not expected to be profitable this year.
In other recent news, uniQure N.V. announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation to its gene therapy candidate AMT-130, aimed at treating Huntington’s disease. This designation, supported by interim data from Phase I/II trials, suggests AMT-130 may slow disease progression, thus offering a potential improvement over existing treatments. The FDA has also previously recognized AMT-130 with Regenerative Medicine Advanced Therapy, Orphan Drug, and Fast Track designations. Additionally, Chardan Capital Markets initiated coverage on uniQure with a Buy rating and a $38 price target, citing the promising potential of the company’s gene therapy pipeline. H.C. Wainwright reaffirmed its Buy rating and set a $70 target, highlighting upcoming milestones for AMT-130 that could enhance its valuation. In corporate developments, uniQure’s CEO, Matthew Kapusta, secured an amended employment agreement with adjusted compensation and severance benefits. These recent developments reflect growing confidence in uniQure’s gene therapy programs and strategic direction.
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