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On Tuesday, H.C. Wainwright analysts reiterated their Buy rating and maintained a $70.00 price target on uniQure BV (NASDAQ: NASDAQ:QURE) stock, aligning with the broader analyst consensus that remains bullish on the company. Trading at $14.48, the stock has significant upside potential to analysts’ targets ranging from $13.15 to $69.77. This decision follows uniQure’s announcement that it held Type B meetings with the U.S. Food and Drug Administration (FDA) regarding its lead candidate, AMT-130, a gene therapy for Huntington’s disease.
During these meetings, the FDA reaffirmed support for an accelerated approval path for AMT-130. The agency provided uniQure with essential details on the statistical analysis plan and Chemistry, Manufacturing, and Controls information, which are crucial for a Biologics License Application submission anticipated in the first quarter of 2026. This could lead to potential approval in the second half of 2026. InvestingPro data shows the company is currently burning through cash, with negative free cash flow of $167.4 million in the last twelve months, though it maintains a strong current ratio of 11.99.
Additionally, uniQure confirmed that three-year top-line data from AMT-130’s ongoing Phase 1/2 study is expected to be available in the third quarter of 2025. Following this, the company plans to hold a pre-BLA meeting with the FDA in the fourth quarter of 2025.
Analysts at H.C. Wainwright emphasized that AMT-130 remains a key value driver for uniQure as it progresses towards potential registration, citing the strength of long-term clinical outcomes and a unique approach to treating early manifest Huntington’s disease.
In other recent news, uniQure N.V. has made significant progress with its gene therapy candidate, AMT-130, for Huntington’s disease. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AMT-130, highlighting its potential to address the urgent need for effective treatments for this debilitating condition. This designation, supported by interim data from Phase I/II trials, is expected to expedite the development and review process of the therapy. Additionally, uniQure has aligned with the FDA on critical aspects of its Biologics License Application (BLA) for AMT-130, with plans to submit in early 2026. The company is also conducting Phase I/II studies to evaluate the safety and efficacy of AMT-130 in the U.S. and Europe. Meanwhile, H.C. Wainwright has reaffirmed a Buy rating and a $70 price target for uniQure, citing confidence in the company’s pipeline and the prospects of AMT-130. The firm also noted uniQure’s strong financial position, with sufficient cash to support operations into 2027. Furthermore, uniQure is advancing its gene therapy candidate AMT-260 for mesial temporal lobe epilepsy, with promising early trial results.
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