Class Action Notice for uniQure N.V. Shareholders
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
0mins
Should l Buy QURE?
Source: Globenewswire
- Class Action Deadline: Rosen Law Firm reminds investors who purchased uniQure N.V. shares between September 24 and October 31, 2025, that they must apply to be lead plaintiffs by April 13, 2026, to protect their rights in the class action lawsuit.
- Lawsuit Background: The lawsuit alleges that uniQure failed to adequately disclose that its pivotal study design for a leading drug candidate was not fully approved by the FDA, resulting in investor losses when the true information became public, highlighting significant transparency and compliance issues within the company.
- Law Firm Credentials: Rosen Law Firm specializes in securities class actions and has recovered over $438 million for investors in 2019 alone, demonstrating a strong track record and extensive experience, which investors should consider when selecting legal counsel to ensure professional support.
- Investor Action Steps: Investors can visit the Rosen Law Firm website or call the toll-free number for more information on how to participate in the lawsuit, ensuring they receive appropriate legal representation in the class action and avoid being ineffective absent members.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy QURE?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on QURE
Wall Street analysts forecast QURE stock price to rise
10 Analyst Rating
8 Buy
2 Hold
0 Sell
Strong Buy
Current: 24.870
Low
33.00
Averages
49.88
High
70.00
Current: 24.870
Low
33.00
Averages
49.88
High
70.00
About QURE
Uniqure NV is a company based in the Netherlands specialized in gene therapy. It seeks to develop one-time administered treatments with potentially curative results for patients suffering from genetic and other devastating diseases. It develops, both internally and through partnerships, a pipeline of gene therapies. It produces adeno-associated virus based, or AAV-based, gene therapies in its own facilities with a proprietary, commercial-scale, current good manufacturing practices, compliant, manufacturing process. AMT-061, the Company’s lead product candidate for patients with hemophilia B, is going through a dosing phase of a pivotal study. AMT-130, the product candidate for patients with Huntington’s disease is in Phase I/II clinical study.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
uniQure Shares Plunge 28% Following FDA Comments on AMT-130 Approval
- FDA Comments Impact: uniQure (QURE) shares fell approximately 28% on Thursday after FDA Commissioner Marty Makary suggested that drugs associated with patient morbidity would not receive approval, directly undermining market confidence in AMT-130.
- AMT-130 Background: This gene therapy aims to treat Huntington's disease, a rare genetically driven neurodegenerative disorder, and uniQure is seeking FDA accelerated approval; however, the FDA's comments may delay this process significantly.
- Clinical Trial Concerns: Makary highlighted that certain drugs showed no benefits in randomized controlled trials and were associated with patient morbidity, emphasizing a cautious stance towards AMT-130, which could lead to regulatory hurdles affecting uniQure's future development.
- Patient Concerns: While Makary expressed sympathy for patients lacking effective treatment options, he firmly stated that drugs with associated morbidity would not be approved, posing a significant challenge to uniQure's market outlook.
See More
Class Action Notice for uniQure N.V. Shareholders
- Class Action Deadline: Rosen Law Firm reminds investors who purchased uniQure N.V. shares between September 24 and October 31, 2025, that they must apply to be lead plaintiffs by April 13, 2026, to protect their rights in the class action lawsuit.
- Lawsuit Background: The lawsuit alleges that uniQure failed to adequately disclose that its pivotal study design for a leading drug candidate was not fully approved by the FDA, resulting in investor losses when the true information became public, highlighting significant transparency and compliance issues within the company.
- Law Firm Credentials: Rosen Law Firm specializes in securities class actions and has recovered over $438 million for investors in 2019 alone, demonstrating a strong track record and extensive experience, which investors should consider when selecting legal counsel to ensure professional support.
- Investor Action Steps: Investors can visit the Rosen Law Firm website or call the toll-free number for more information on how to participate in the lawsuit, ensuring they receive appropriate legal representation in the class action and avoid being ineffective absent members.
See More
FDA Tightens Stance on Rare Disease Drug Approvals
- FDA Policy Tightening: In an interview, FDA Commissioner Makary defended the agency's stricter stance on rare disease drug approvals, mentioning a product that showed no benefit in a randomized trial and had associated morbidity, indicating a more cautious approach that could slow future drug approvals.
- uniQure Stock Plunge: Following Makary's comments, uniQure's shares plummeted 32% on Thursday, reflecting market concerns over the approval prospects of its Huntington's disease gene therapy AMT-130, especially after the FDA deemed early trial data insufficient to support an application.
- Market Sentiment Shift: Despite the stock drop, retail sentiment around QURE on Stocktwits shifted from 'bearish' to 'bullish' within 24 hours, indicating investor optimism about the company's plans to communicate with the FDA regarding a path forward for approval.
- Competitive Drug Analysis: Analysts noted that Makary's comments could refer to either uniQure's AMT-130 or Regenxbio's RGX-121, the latter of which was not approved by the FDA due to insufficient evidence of effectiveness, highlighting the agency's rigorous scrutiny that may impact the entire industry's R&D direction.
See More
uniQure Investors Encouraged to Discuss Legal Options
- Legal Claim Investigation: Faruq & Faruqi LLP is investigating potential claims against uniQure N.V., particularly for investors who purchased securities between September 24, 2025, and October 31, 2025, indicating possible legal risks.
- Investor Contact Information: Securities Litigation Partner Josh Wilson encourages affected investors to contact him directly, providing phone numbers 877-247-4292 and 212-983-9330 (Ext. 1310) to discuss their legal rights and options.
- Class Action Deadline: Investors should note that the deadline to seek the role of lead plaintiff in the federal securities class action is April 13, 2026, which may affect their rights to claim.
- Law Firm Background: Faruq & Faruqi is a leading national securities law firm focused on providing legal support to investors, demonstrating the firm's commitment to protecting investor rights.
See More
Class Action Reminder for uniQure N.V. Shareholders
- Lawsuit Background: Robbins LLP reminds all investors who purchased uniQure N.V. (NASDAQ:QURE) ordinary shares between September 24, 2025, and October 31, 2025, that a class action has been filed against the company, alleging misleading statements regarding the likelihood of FDA approval.
- Allegation Details: The complaint alleges that uniQure failed to disclose that the design of its pivotal study was not fully approved by the FDA and downplayed the likelihood of needing to delay its BLA submission timeline due to additional studies despite claiming successful results.
- Stock Price Impact: Following the announcement on November 3, 2025, regarding feedback from the FDA on AMT-130, uniQure's stock price plummeted by $33.40, a decline of over 49%, from a closing price of $67.69 on October 31, 2025, to $34.29.
- Shareholder Action Advice: Shareholders wishing to serve as lead plaintiffs must submit their papers by April 13, 2026, to represent other class members in the litigation, and they do not need to participate in the case to be eligible for recovery.
See More
Class Action Notice for UniQure N.V. Investors
- Class Action Notice: The Portnoy Law Firm advises investors of UniQure N.V. regarding a class action for those who purchased securities between September 24, 2025, and October 31, 2025, with a deadline of April 13, 2026, for filing a lead plaintiff motion to protect their legal rights.
- FDA Feedback Impact: On November 3, 2025, UniQure announced that the FDA indicated during a meeting regarding the Biologics License Application for AMT-130 that prior clinical trial data may not be sufficient for BLA submission, marking a significant shift in the regulatory dialogue and creating uncertainty around the submission timeline.
- Stock Price Plunge: Following the FDA's feedback, UniQure's stock price plummeted by $33.40, or 49.34%, closing at $34.29 per share on November 3, 2025, reflecting market concerns about the company's future prospects and the viability of its gene therapy.
- Legal Support and Compensation: The Portnoy Law Firm offers complimentary case evaluations to assist investors in recovering losses due to corporate misconduct, with its founding partner having successfully recovered over $5.5 billion for aggrieved investors, underscoring its commitment to investor rights protection.
See More
uniQure Shares Plunge 28% Following FDA Comments on AMT-130 Approval
- FDA Comments Impact: uniQure (QURE) shares fell approximately 28% on Thursday after FDA Commissioner Marty Makary suggested that drugs associated with patient morbidity would not receive approval, directly undermining market confidence in AMT-130.
- AMT-130 Background: This gene therapy aims to treat Huntington's disease, a rare genetically driven neurodegenerative disorder, and uniQure is seeking FDA accelerated approval; however, the FDA's comments may delay this process significantly.
- Clinical Trial Concerns: Makary highlighted that certain drugs showed no benefits in randomized controlled trials and were associated with patient morbidity, emphasizing a cautious stance towards AMT-130, which could lead to regulatory hurdles affecting uniQure's future development.
- Patient Concerns: While Makary expressed sympathy for patients lacking effective treatment options, he firmly stated that drugs with associated morbidity would not be approved, posing a significant challenge to uniQure's market outlook.
See More
Class Action Notice for uniQure N.V. Shareholders
- Class Action Deadline: Rosen Law Firm reminds investors who purchased uniQure N.V. shares between September 24 and October 31, 2025, that they must apply to be lead plaintiffs by April 13, 2026, to protect their rights in the class action lawsuit.
- Lawsuit Background: The lawsuit alleges that uniQure failed to adequately disclose that its pivotal study design for a leading drug candidate was not fully approved by the FDA, resulting in investor losses when the true information became public, highlighting significant transparency and compliance issues within the company.
- Law Firm Credentials: Rosen Law Firm specializes in securities class actions and has recovered over $438 million for investors in 2019 alone, demonstrating a strong track record and extensive experience, which investors should consider when selecting legal counsel to ensure professional support.
- Investor Action Steps: Investors can visit the Rosen Law Firm website or call the toll-free number for more information on how to participate in the lawsuit, ensuring they receive appropriate legal representation in the class action and avoid being ineffective absent members.
See More
FDA Tightens Stance on Rare Disease Drug Approvals
- FDA Policy Tightening: In an interview, FDA Commissioner Makary defended the agency's stricter stance on rare disease drug approvals, mentioning a product that showed no benefit in a randomized trial and had associated morbidity, indicating a more cautious approach that could slow future drug approvals.
- uniQure Stock Plunge: Following Makary's comments, uniQure's shares plummeted 32% on Thursday, reflecting market concerns over the approval prospects of its Huntington's disease gene therapy AMT-130, especially after the FDA deemed early trial data insufficient to support an application.
- Market Sentiment Shift: Despite the stock drop, retail sentiment around QURE on Stocktwits shifted from 'bearish' to 'bullish' within 24 hours, indicating investor optimism about the company's plans to communicate with the FDA regarding a path forward for approval.
- Competitive Drug Analysis: Analysts noted that Makary's comments could refer to either uniQure's AMT-130 or Regenxbio's RGX-121, the latter of which was not approved by the FDA due to insufficient evidence of effectiveness, highlighting the agency's rigorous scrutiny that may impact the entire industry's R&D direction.
See More
uniQure Investors Encouraged to Discuss Legal Options
- Legal Claim Investigation: Faruq & Faruqi LLP is investigating potential claims against uniQure N.V., particularly for investors who purchased securities between September 24, 2025, and October 31, 2025, indicating possible legal risks.
- Investor Contact Information: Securities Litigation Partner Josh Wilson encourages affected investors to contact him directly, providing phone numbers 877-247-4292 and 212-983-9330 (Ext. 1310) to discuss their legal rights and options.
- Class Action Deadline: Investors should note that the deadline to seek the role of lead plaintiff in the federal securities class action is April 13, 2026, which may affect their rights to claim.
- Law Firm Background: Faruq & Faruqi is a leading national securities law firm focused on providing legal support to investors, demonstrating the firm's commitment to protecting investor rights.
See More
Class Action Reminder for uniQure N.V. Shareholders
- Lawsuit Background: Robbins LLP reminds all investors who purchased uniQure N.V. (NASDAQ:QURE) ordinary shares between September 24, 2025, and October 31, 2025, that a class action has been filed against the company, alleging misleading statements regarding the likelihood of FDA approval.
- Allegation Details: The complaint alleges that uniQure failed to disclose that the design of its pivotal study was not fully approved by the FDA and downplayed the likelihood of needing to delay its BLA submission timeline due to additional studies despite claiming successful results.
- Stock Price Impact: Following the announcement on November 3, 2025, regarding feedback from the FDA on AMT-130, uniQure's stock price plummeted by $33.40, a decline of over 49%, from a closing price of $67.69 on October 31, 2025, to $34.29.
- Shareholder Action Advice: Shareholders wishing to serve as lead plaintiffs must submit their papers by April 13, 2026, to represent other class members in the litigation, and they do not need to participate in the case to be eligible for recovery.
See More
Class Action Notice for UniQure N.V. Investors
- Class Action Notice: The Portnoy Law Firm advises investors of UniQure N.V. regarding a class action for those who purchased securities between September 24, 2025, and October 31, 2025, with a deadline of April 13, 2026, for filing a lead plaintiff motion to protect their legal rights.
- FDA Feedback Impact: On November 3, 2025, UniQure announced that the FDA indicated during a meeting regarding the Biologics License Application for AMT-130 that prior clinical trial data may not be sufficient for BLA submission, marking a significant shift in the regulatory dialogue and creating uncertainty around the submission timeline.
- Stock Price Plunge: Following the FDA's feedback, UniQure's stock price plummeted by $33.40, or 49.34%, closing at $34.29 per share on November 3, 2025, reflecting market concerns about the company's future prospects and the viability of its gene therapy.
- Legal Support and Compensation: The Portnoy Law Firm offers complimentary case evaluations to assist investors in recovering losses due to corporate misconduct, with its founding partner having successfully recovered over $5.5 billion for aggrieved investors, underscoring its commitment to investor rights protection.
See More
