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 Viewpoint - uniQure N.V. is facing stock price decline due to unfavorable feedback from the FDA regarding its investigational gene therapy AMT-130 for Huntington's disease, which may not support a Biologics License Application submission [2][3][4]. Group 1: FDA Feedback - The FDA's final meeting minutes indicate that data from Phase 1/2 studies of AMT-130 are unlikely to provide primary evidence for a BLA submission [3]. - uniQure plans to urgently request a follow-up meeting with the FDA in the first quarter of 2026 to discuss the feedback received [3]. Group 2: Market Reaction - Following the FDA's feedback, uniQure's stock has decreased by 11.24%, trading at $22.60 [5]. - Analysts express surprise at the FDA's change in guidance, noting the numerous interactions between uniQure and the FDA since November 2024 [4]. Group 3: Future Outlook - The path and timing for the BLA submission for AMT-130 remain unclear, leading to continued pressure on uniQure's stock until a clearer regulatory submission pathway is established [4].

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].

Core Insights - The law firm 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 data to support a Biologics License Application (BLA) submission [2] - Following this announcement, uniQure's stock price plummeted over 50%, from $67.69 on October 31, 2025, to $34.29 on November 3, 2025 [3] Company Developments - uniQure's AMT-130, an investigational gene therapy for Huntington's disease, is facing regulatory challenges as the FDA no longer considers the Phase I/II study data adequate for BLA submission [2] - The timing for the BLA submission for AMT-130 has become uncertain due to the FDA's feedback [2] Market Reaction - The significant drop in uniQure's stock price reflects investor concerns regarding the viability of AMT-130 and its potential market approval [3]

Core Insights - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving uniQure N.V. and its officers or directors [1] - uniQure announced feedback from the FDA indicating that data from Phase I/II studies of its investigational gene therapy AMT-130 may not be sufficient for a Biologics License Application (BLA) submission, leading to a significant drop in stock price [2] Group 1: Company Developments - On November 3, 2025, uniQure received feedback from the FDA during a pre-BLA meeting regarding AMT-130, a gene therapy for Huntington's disease [2] - The FDA's feedback represents a key shift from previous communications, causing uncertainty about the timing of the BLA submission for AMT-130 [2] - Following the announcement, uniQure's stock price fell by $33.40, or 49.34%, closing at $34.29 per share [2] Group 2: Legal Investigations - Pomerantz LLP is actively investigating claims on behalf of investors of uniQure regarding potential securities fraud [1] - The firm has a long history in corporate and securities class litigation, having recovered significant damages for victims of securities fraud [3]

Core Viewpoint - The law firm Kessler Topaz Meltzer & Check, LLP is investigating potential violations of federal securities laws related to uniQure N.V. following a significant drop in its stock price after the FDA's notification regarding its investigational gene therapy AMT-130 for Huntington's disease [1][2][3]. Group 1: Company Developments - On November 3, 2025, uniQure announced that the FDA indicated the data for its AMT-130 did not provide sufficient evidence to support its Biologics License Application (BLA) submission [2]. - The FDA no longer agrees that data from the Phase I/II studies of AMT-130 may be adequate for the BLA submission, leading to uncertainty regarding the timing of the submission [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].