Core Viewpoint - The law firm Kessler Topaz Meltzer & Check, LLP is investigating potential violations of federal securities laws on behalf of investors of uniQure N.V. following a press release from the company regarding its investigational gene therapy AMT-130 for Huntington's disease [1]. Group 1 - On November 3, 2025, uniQure announced that the FDA informed the company that the data for AMT-130 did not provide sufficient evidence to support its Biologics License Application [1].

Core Viewpoint - UniQure N.V. is under investigation for potential securities law violations following a significant drop in its stock price after the FDA deemed its clinical data for an experimental gene therapy insufficient [2][4]. Group 1: Company Overview - UniQure's shares fell by as much as 66% after the FDA's announcement regarding its gene therapy for Huntington's disease [2]. - The FDA's decision represents a considerable shift from previous communications between the regulator and UniQure [2]. Group 2: Investigation Details - Block & Leviton is investigating UniQure's disclosures to determine if there were any violations of securities laws [4]. - The firm is reaching out to investors who have lost money in their UniQure investments to discuss potential recovery options [1][3]. Group 3: Investor Actions - Investors who purchased UniQure common stock and experienced a decline in share value may be eligible to participate in the investigation [3]. - Block & Leviton encourages affected investors to contact them for more information on recovery [5][7].

Core Insights - Holzer & Holzer, LLC is investigating uniQure N.V. for potential compliance issues with federal securities laws following a recent FDA meeting [1] - uniQure disclosed that the FDA no longer agrees that data from Phase I/II studies of AMT-130 may be adequate for a Biologics License Application submission [1] - The announcement led to a decline in uniQure's stock price [1] Company Summary - uniQure N.V. is involved in the development of gene therapies, specifically AMT-130, which is under scrutiny due to regulatory feedback from the FDA [1] - The company had a pre-BLA meeting with the FDA, which raised concerns about the adequacy of its clinical data [1] Legal Context - Holzer & Holzer, LLC is a law firm specializing in securities litigation and is reaching out to investors who may have suffered losses due to the recent developments with uniQure [2][3] - The firm has a history of recovering significant amounts for shareholders affected by corporate misconduct [3]

Market Overview - U.S. stocks showed mixed performance, with the Dow Jones index falling by 0.41% to 47,369.42, while the NASDAQ rose by 0.54% to 23,853.68 and the S&P 500 gained 0.22% to 6,855.42 [1] - Consumer discretionary shares increased by 1.8%, while materials stocks decreased by 0.6% [1] Economic Indicators - The ISM manufacturing PMI decreased to 48.7 in October from 49.1 in the previous month, falling short of market expectations of 49.5 [2][11] - The S&P Global manufacturing PMI rose to 52.5 in October from 52.0 in September, surpassing the preliminary reading of 52.2 [11] Commodity Market - Oil prices fell by 0.1% to $60.93, while gold prices increased by 0.4% to $4,011.80 [5] - Silver prices decreased by 0.5% to $47.905, and copper prices fell by 0.9% to $5.0420 [5] Company News - Cipher Mining Inc. shares surged by 22% to $22.82 following a $5.5 billion, 15-year lease agreement with Amazon Web Services for 300 MW of AI workload space and power [9] - Resolute Holdings Management, Inc. saw an 88% increase in shares to $138.76 after reporting quarterly financial results [9] - Tharimmune, Inc. shares rose by 14% to $3.35 after entering a $540 million private placement for its Canton Network Blockchain strategy [9] - uniQure N.V. shares dropped by 50% to $33.64 after receiving FDA feedback regarding its investigational gene therapy AMT-130 [9] - Alvotech shares fell by 33% to $5.13 after the FDA issued a complete response letter for its biosimilar candidate AVT05 [9] - ALPS Group Inc shares decreased by 50% to $1.29 following the announcement of a public offering pricing [9]

Core Viewpoint - The FDA's feedback on uniQure's investigational gene therapy AMT-130 for Huntington's disease has led to a significant decline in the company's stock, indicating a shift in regulatory expectations and uncertainty regarding the BLA submission timeline [1][3][4]. Group 1: FDA Feedback and Company Response - The FDA expressed disagreement with uniQure's interpretation of data from Phase 1/2 studies of AMT-130, suggesting it may not be sufficient for a BLA submission [2][4]. - This feedback represents a notable change from previous communications with the FDA, which had indicated that the data could support a BLA submission under the Accelerated Approval pathway [3][4]. - The company plans to urgently engage with the FDA to explore options for the timely accelerated approval of AMT-130 [3][5]. Group 2: Market Reaction - Following the FDA's feedback, uniQure's stock price fell by 53.98%, trading at $31.15 at the time of publication [6]. Group 3: Future Plans - In addition to working with the FDA, uniQure intends to engage with other regulatory agencies, including those in the European Union and the United Kingdom, to advance discussions regarding AMT-130 [5].

LOS ANGELES--(BUSINESS WIRE)---- $QURE--QURE Investors Have Opportunity to Join uniQure N.V. Fraud Investigation with the Schall Law Firm. ...

Core Insights - uniQure N.V. (NASDAQ:QURE) has been recognized as one of the 12 best-performing stocks over the last three months, with analysts raising price targets following positive trial results for its gene therapy AMT-130 [1][2] Group 1: Analyst Ratings and Price Targets - RBC Capital reiterated a Buy rating on uniQure N.V. and increased its price target from $55 to $65 [1] - H.C. Wainwright raised its price target from $70 to $110 while maintaining a Buy rating [2] Group 2: Clinical Trial Results - The company reported positive topline data from its Phase I/II study of AMT-130 for Huntington's disease, indicating that the therapy slowed disease progression [2][3] - The pivotal study met its primary endpoint, showing that a high dose of AMT-130 slowed the disease by 75% over 36 months, with the treatment being generally safe and well-tolerated [3] Group 3: Regulatory Designations and Future Plans - AMT-130 has received Breakthrough Therapy designation and Regenerative Medicine Advanced Therapy (RMAT) status from the FDA [3] - uniQure N.V. plans to submit a biologics license application (BLA) in the first quarter of 2026 and aims to launch the treatment in the US later that year [3]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2][3] - The news team covers key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2] - Proactive focuses on medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [2][3] Group 2 - The team delivers news and insights across various sectors including biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] - Proactive adopts technology to enhance workflows and improve content production [4][5] - All content published by Proactive is edited and authored by humans, ensuring adherence to best practices in content production and search engine optimization [5]

Core Insights - Significant investors have adopted a bullish stance on uniQure, with 60% of trades reflecting bullish expectations and 35% bearish [1] - The projected price targets for uniQure range from $10.0 to $100.0 over the past three months [2] - The options trading activity indicates a notable interest in both call and put options, with a total of $1,759,721 in puts and $3,331,788 in calls [1] Options Activity - In the last 30 days, notable options activity includes a mix of bullish and bearish trades, with significant trades involving calls and puts at various strike prices [4][9] - The volume of options traded for uniQure reached 8,655,320, with the stock price currently at $27.91, reflecting a decline of 58.77% [15] - The average target price from expert opinions on uniQure is $110.0, indicating a strong bullish outlook from analysts [12][13] Company Overview - uniQure NV is a gene therapy company focused on developing treatments for genetic diseases, including hemophilia, Huntington's disease, and cardiovascular diseases [10] - The company collaborates with Bristol Myers Squibb for the development of gene therapies targeting cardiovascular diseases [11]

LOS ANGELES--(BUSINESS WIRE)--uniQure N.V. Investigated for Securities Fraud Violations - Contact the DJS Law Group to Discuss Your Rights – QURE. ...