Class Action Reminder for uniQure N.V. Shareholders
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 26 2026
0mins
Source: PRnewswire
- 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.
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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: 24.190
Low
33.00
Averages
49.88
High
70.00
Current: 24.190
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.
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- Commissioner Resignation: Marty Makary's resignation from the FDA, following clashes with the Trump administration, has led to Kyle Diamantas stepping in as acting commissioner, potentially shifting FDA policy and its relationship with the pharmaceutical industry.
- Positive Market Reaction: Following Makary's exit, shares of Replimune (REPL) and uniQure (QURE) surged by 7% and 5%, respectively, indicating market optimism regarding the new leadership and future regulatory approaches.
- Strong Industry Backlash: Replimune faced significant criticism after the FDA rejected its melanoma therapy RP1, and Makary's departure may alter the regulatory landscape, impacting the company's strategic direction moving forward.
- Investor Sentiment Shift: While REPL has fallen 49% over the past year, QURE has gained 120%, reflecting differing investor sentiments towards the future prospects of both companies, especially in light of potential FDA policy changes.
See More
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- Makary Resignation: FDA Commissioner Marty Makary resigned on December 18, 2025, concluding a controversial tenure marked by criticism over the government's COVID-19 response and drug approval processes, which drew backlash from various stakeholders.
- Acting Commissioner Appointment: President Trump announced that Kyle Diamantas will temporarily take over as acting commissioner, having previously served as the top food official at the FDA, and will need to navigate the complex drug approval landscape left by Makary.
- Internal Turmoil Intensifies: Under Makary's leadership, staff morale at the FDA plummeted due to layoffs and departures, notably that of cancer regulator Richard Pazdur, leading to increased distrust in leadership and impacting the agency's stability.
- Drug Approval Controversies: During Makary's tenure, the FDA rejected several rare disease treatments, raising concerns within the pharmaceutical industry, particularly as negotiations for the reauthorization of the Prescription Drug User Fee Act highlighted the industry's sensitivity to leadership changes at the FDA.
See More
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- Stock Price Surge: Following reports of potential dismissal of FDA Commissioner Marty Makary, shares of Replimune (REPL) and uniQure (QURE) surged by 17% and 15% respectively, indicating market optimism regarding regulatory improvements under new leadership.
- Industry Response: The pharmaceutical industry has expressed dissatisfaction with Makary's drug review policies, citing inconsistencies and overly restrictive processes that hinder innovative drug approvals, suggesting that new leadership could accelerate approval timelines and restore clearer regulatory guidance.
- Potential Beneficiaries: Companies like Replimune and uniQure, which have publicly clashed with the FDA, are seen as potential beneficiaries of new leadership, with Replimune's melanoma therapy RP1 being rejected and uniQure's Huntington's disease gene therapy AMT-130 facing significant shifts in review policy.
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See More
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Market Reaction: Shares of ClearPoint Neuro have seen a significant increase following reports from the Wall Street Journal regarding potential changes in leadership at the FDA.
Leadership Changes: The reports suggest that former President Trump is considering firing FDA Commissioner Marty Makary, which has implications for regulatory processes in the biotech industry.
Investor Sentiment: The news has sparked interest among investors, leading to a spike in ClearPoint Neuro's stock prices as market participants react to the potential shifts in FDA oversight.
See More
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- Revenue Growth: uniQure reported revenue of $3.6 million for Q1 2026, a 125% increase from $1.6 million in the prior year, primarily driven by increased licensing revenue, indicating a strengthening market position and commercialization potential.
- R&D Expense Adjustment: Research and development expenses were $29.2 million, down from $36.1 million a year ago, mainly due to reduced external spending and personnel costs, providing greater financial flexibility for future clinical trials.
- Cash Flow Status: As of March 31, 2026, the company had $586.6 million in cash, cash equivalents, and investment securities, expected to fund operations into the second half of 2029, reflecting robust financial management.
- Clinical Trial Progress: uniQure is preparing to submit a marketing authorization application for AMT-130 in the U.K. and plans to hold a Type B FDA meeting in Q2 to discuss new clinical study designs, laying the groundwork for future product launches.
See More
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- Earnings Highlights: uniQure reported a Q1 GAAP EPS of -$0.85, beating expectations by $0.01, indicating efforts in cost control, although overall financial performance still requires improvement.
- Revenue Growth: The company generated $3.56M in revenue, a 126.8% year-over-year increase, but fell short of expectations by $1.71M, reflecting market demand fluctuations and sales challenges.
- License Revenue Increase: The $2.0M increase in license revenue compared to the prior period suggests that the company's strategic focus on intellectual property is beginning to pay off, potentially laying the groundwork for future revenue growth.
- Market Reaction: Despite mixed financial indicators, uniQure's stock rose following regulatory updates, indicating market optimism regarding the prospects of its gene therapy asset AMT-130.
See More
