uniQure to Announce Q4 Earnings on March 2
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
0mins
Should l Buy QURE?
Source: seekingalpha
- Earnings Announcement: uniQure is set to release its Q4 2023 earnings results on March 2 before the market opens, with investors keenly awaiting insights into its financial performance and future outlook.
- Earnings Expectations: The consensus EPS estimate stands at -$0.93, indicating challenges in profitability that could potentially affect investor confidence and stock performance.
- Revenue Estimate Changes: Over the past three months, revenue estimates have seen one upward revision and four downward revisions, with the current estimate at $5.56 million, reflecting a cautious market sentiment regarding uniQure's future revenue growth.
- Analyst Rating Dynamics: Despite four upward revisions and no downward adjustments in EPS estimates over the last three months, the overall downward trend in revenue expectations may dampen market sentiment towards uniQure's stock performance.
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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: 17.115
Low
33.00
Averages
49.88
High
70.00
Current: 17.115
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 to Announce Q4 Earnings on March 2
- Earnings Announcement: uniQure is set to release its Q4 2023 earnings results on March 2 before the market opens, with investors keenly awaiting insights into its financial performance and future outlook.
- Earnings Expectations: The consensus EPS estimate stands at -$0.93, indicating challenges in profitability that could potentially affect investor confidence and stock performance.
- Revenue Estimate Changes: Over the past three months, revenue estimates have seen one upward revision and four downward revisions, with the current estimate at $5.56 million, reflecting a cautious market sentiment regarding uniQure's future revenue growth.
- Analyst Rating Dynamics: Despite four upward revisions and no downward adjustments in EPS estimates over the last three months, the overall downward trend in revenue expectations may dampen market sentiment towards uniQure's stock performance.
See More
FDA Raises Concerns Over Invasive Gene Therapies
- Regulatory Pressure Intensifies: FDA Commissioner Marty Makary's concerns over invasive gene therapies led to a 31% drop in UniQure's AMT-130 stock, hitting a five-month low, indicating investor panic over regulatory prospects that could impact the company's funding and R&D efforts.
- Divergent Analyst Opinions: While RBC Capital Markets views Makary's comments as directed at UniQure, Leerink suggests they may refer to Regenxbio's RGX-121, reflecting market uncertainty regarding FDA regulatory policies that could erode investor confidence.
- Clinical Trial Challenges: Regenxbio's RGX-121 recently faced a Complete Response Letter from the FDA, citing uncertainties around study population definitions and surrogate endpoints, further heightening market concerns about its future development and competitive position.
- Opportunities in Personalized Therapies: Despite challenges, the FDA's recent draft guidance offers potential accelerated approvals for highly personalized gene therapies, indicating regulatory flexibility in treating ultra-rare conditions, which may present new growth opportunities for related companies.
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
uniQure to Announce Q4 Earnings on March 2
- Earnings Announcement: uniQure is set to release its Q4 2023 earnings results on March 2 before the market opens, with investors keenly awaiting insights into its financial performance and future outlook.
- Earnings Expectations: The consensus EPS estimate stands at -$0.93, indicating challenges in profitability that could potentially affect investor confidence and stock performance.
- Revenue Estimate Changes: Over the past three months, revenue estimates have seen one upward revision and four downward revisions, with the current estimate at $5.56 million, reflecting a cautious market sentiment regarding uniQure's future revenue growth.
- Analyst Rating Dynamics: Despite four upward revisions and no downward adjustments in EPS estimates over the last three months, the overall downward trend in revenue expectations may dampen market sentiment towards uniQure's stock performance.
See More
FDA Raises Concerns Over Invasive Gene Therapies
- Regulatory Pressure Intensifies: FDA Commissioner Marty Makary's concerns over invasive gene therapies led to a 31% drop in UniQure's AMT-130 stock, hitting a five-month low, indicating investor panic over regulatory prospects that could impact the company's funding and R&D efforts.
- Divergent Analyst Opinions: While RBC Capital Markets views Makary's comments as directed at UniQure, Leerink suggests they may refer to Regenxbio's RGX-121, reflecting market uncertainty regarding FDA regulatory policies that could erode investor confidence.
- Clinical Trial Challenges: Regenxbio's RGX-121 recently faced a Complete Response Letter from the FDA, citing uncertainties around study population definitions and surrogate endpoints, further heightening market concerns about its future development and competitive position.
- Opportunities in Personalized Therapies: Despite challenges, the FDA's recent draft guidance offers potential accelerated approvals for highly personalized gene therapies, indicating regulatory flexibility in treating ultra-rare conditions, which may present new growth opportunities for related companies.
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
