Core Points - Kessler Topaz Meltzer & Check, LLP is investigating potential violations of federal securities laws on behalf of investors of uniQure N.V. [1] - On November 3, 2025, uniQure announced that the FDA indicated insufficient evidence from its AMT-130 gene therapy studies to support a Biologics License Application (BLA) [2] - Following this announcement, uniQure's stock price dropped over 50%, from $67.69 on October 31, 2025, to $34.29 on November 3, 2025 [3] Company Summary - uniQure N.V. is focused on developing gene therapies, specifically for conditions like Huntington's disease [2] - The company is currently facing challenges regarding the regulatory approval process for its investigational therapy AMT-130 [2] Legal and Regulatory Context - The investigation by Kessler Topaz Meltzer & Check, LLP highlights potential legal implications for uniQure related to securities laws [1] - The FDA's feedback on the adequacy of clinical trial data for AMT-130 raises concerns about the company's future regulatory submissions [2]

uniQure NV (NASDAQ:QURE) stock has plunged around 31% over the last month, as per data from Benzinga Pro. • uniQure stock is trading at depressed levels. Where are QURE shares going?UniQure stock reached as high as $22 on Tuesday before falling during the trading hours. However, there is no news to justify the movement.In November, the U.S. Food and Drug Administration (FDA) provided feedback to uniQure regarding its investigational gene therapy for Huntington's disease, causing the stock to decline.uniQure ...

Core Viewpoint - The law firm Kessler Topaz Meltzer & Check, LLP is investigating potential violations of federal securities laws on behalf of investors in uniQure N.V. following significant stock price decline after FDA feedback on its gene therapy AMT-130 [1][2][3] Group 1: Company Developments - On November 3, 2025, uniQure announced that the FDA indicated the data for its investigational gene therapy AMT-130 for Huntington's disease was insufficient to support its Biologics License Application (BLA) [2] - uniQure believes the FDA no longer considers the Phase I/II study data adequate for BLA submission, leading to uncertainty regarding the timing of the BLA submission for AMT-130 [2] Group 2: Market Reaction - Following the FDA's announcement, uniQure's stock price plummeted over 50%, dropping from $67.69 on October 31, 2025, to $34.29 on November 3, 2025 [3]

Core Viewpoint - The law firm Kessler Topaz Meltzer & Check, LLP is investigating potential violations of federal securities laws on behalf of investors in uniQure N.V. following significant stock price decline after FDA feedback on its gene therapy AMT-130 [1][4]. Group 1: Company Developments - On November 3, 2025, uniQure announced that the FDA indicated the data for its investigational gene therapy AMT-130 did not provide sufficient evidence to support its Biologics License Application (BLA) [2]. - uniQure believes the FDA no longer considers the Phase I/II study data adequate for BLA submission, leading to uncertainty regarding the timing of the BLA submission for AMT-130 [2]. Group 2: Market Reaction - Following the announcement, uniQure's stock price plummeted over 50%, dropping from $67.69 on October 31, 2025, to $34.29 on November 3, 2025 [3].

uniQure N.V. (NASDAQ:QURE) has a Return on Invested Capital (ROIC) of -23.80% and a Weighted Average Cost of Capital (WACC) of 11.72%, indicating it generates returns below its cost of capital.REGENXBIO Inc. and Voyager Therapeutics, Inc. show even lower efficiency in generating returns over their cost of capital compared to uniQure.Blueprint Medicines Corporation exhibits the highest potential for improvement among the peers, with a ROIC to WACC ratio closest to breaking even.uniQure N.V. (NASDAQ:QURE) is ...

Core Insights - The article identifies 7 hidden multibagger stocks that have shown significant returns and potential upside, emphasizing the importance of selecting stocks with strong fundamentals and growth prospects [1][5]. Group 1: Stock Selection Criteria - Stocks were selected based on a minimum return of 75% over the past year and a market capitalization of at least $1 billion [1]. - The shortlisted stocks were required to have at least 30% potential upside, leading to a ranking of the top 7 stocks [1]. Group 2: Market Outlook - The S&P 500 index is expected to show positive performance for the third consecutive year, with AI adoption potentially driving a productivity boom similar to the late 90s [3]. - Goldman Sachs anticipates that reducing tariff uncertainties could enhance economic security, leading to increased capital deployment in defense, energy, and infrastructure sectors [4]. Group 3: Individual Stock Highlights - **Praxis Precision Medicines, Inc. (NASDAQ:PRAX)**: Achieved a 264% price return over the past year with a potential upside of 33%. The company reported positive results from a key study on a treatment for severe epilepsy [6][8]. - **Solaris Resources Inc. (NYSEAMERICAN:SLSR)**: Recorded a 139% price return with a potential upside of 43.36%. The company is focused on copper and other minerals, with a significant project expected to produce 4.5 million tonnes of Copper Equivalent [10][11]. - **Ouster Inc. (NASDAQ:OUST)**: Experienced a 138.5% price return and has a potential upside of 55.37%. The company is noted for its strong client base and growth prospects in lidar sensor technology [14][15]. - **Xeris Biopharma Holdings, Inc. (NASDAQ:XERS)**: Achieved a 75% price return with a potential upside of 61.3%. The company is advancing a new formulation for hypothyroidism treatment [18][19]. - **Applied Digital Corporation (NASDAQ:APLD)**: Saw a 192.6% price return and has a potential upside of 62.36%. The company is investing in advanced cooling systems for data centers, positioning itself for growth in the AI sector [21][22]. - **IREN Limited (NASDAQ:IREN)**: Recorded a 190.5% price return with a potential upside of 91.23%. Despite recent funding challenges, the company has strong fundamentals supported by a significant AI contract with Microsoft [24][26]. - **UniQURE (NASDAQ:QURE)**: Achieved a 186% price return with a potential upside of 117.16%. The company is developing a gene therapy for Huntington's disease, although it faces regulatory challenges [28][29].

uniQure N.V. (NASDAQ:QURE) stock is trading lower on Thursday. • QURE shares are retreating from recent levels. Check the market position here.The gene therapy company received final meeting minutes from the U.S. Food and Drug Administration regarding a pre-Biologics License Application (BLA) meeting held in October to discuss the application for AMT-130, an investigational gene therapy for Huntington’s disease (HD). In the final meeting minutes, and consistent with uniQure’s November press release, the FDA ...

We came across a bearish thesis on uniQure N.V. on augur’s substack. In this article, we will summarize the bulls’ thesis on QURE. uniQure N.V.'s share was trading at $27.51 as of November 28th. QURE’s forward P/E was 27.93 according to Yahoo Finance. Why Core Scientific Inc. (CORZ) Performed Worst On Tuesday? goodluz/Shutterstock.com uniQure N.V. develops treatments for patients suffering from rare and other devastating diseases in the United States. QURE’s AMT-130 gene therapy faces significant scient ...

Group 1 - uniQure N.V. (NASDAQ:QURE) is considered one of the most oversold biotech stocks, with a reaffirmed Market Perform rating from William Blair [1] - The company is facing regulatory challenges regarding its AMT-130 therapy, as the FDA no longer deems the results from Phase 1/2 studies sufficient for a Biologics License Application (BLA) [2] - uniQure anticipates receiving final minutes from the pre-BLA meeting within 30 days and plans to engage proactively with the FDA for accelerated approval of AMT-130 [3] Group 2 - The strong clinical results released last month and early interest from patients and physicians for the Huntington's disease medication may lead to pressure on regulators for a quicker BLA submission [1]

Core Viewpoint - The law firm Kessler Topaz Meltzer & Check, LLP is investigating potential violations of federal securities laws on behalf of investors in uniQure N.V. following significant stock price decline after FDA feedback on its gene therapy AMT-130 [1][4]. Group 1: Company Developments - On November 3, 2025, uniQure announced that the FDA indicated the data for its investigational gene therapy AMT-130 did not provide sufficient evidence to support its Biologics License Application (BLA) [2]. - The FDA no longer agrees that data from the Phase I/II studies of AMT-130 may be adequate for BLA submission, leading to uncertainty regarding the timing of the BLA submission [2]. Group 2: Market Reaction - Following the announcement, uniQure's stock price plummeted over 50%, dropping from $67.69 on October 31, 2025, to $34.29 on November 3, 2025 [3].