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uniQure N.V. (QURE)
NASDAQ:QURE
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uniQure (QURE) AI Stock Analysis

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QURE

uniQure

(NASDAQ:QURE)

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Neutral 43 (OpenAI - 4o)
Rating:43Neutral
Price Target:
$27.00
▼(-2.28% Downside)
uniQure's overall stock score is primarily impacted by its financial challenges, including negative profitability and cash flow issues. While technical indicators suggest bearish momentum, the earnings call provided some optimism with promising pipeline developments. However, regulatory setbacks and valuation concerns weigh heavily on the stock's attractiveness.
Positive Factors
Pipeline Advancements
Significant progress in the therapeutic pipeline, particularly for Huntington's disease, indicates strong R&D capabilities and potential future revenue streams.
Strong Cash Position
A robust cash position provides financial flexibility to support ongoing R&D and operational activities, ensuring sustainability and growth potential.
Revenue Growth
The increase in revenue reflects successful product commercialization and effective partnerships, enhancing long-term financial stability.
Negative Factors
Regulatory Challenges
Regulatory setbacks for AMT-130 introduce uncertainty in approval timelines, potentially delaying market entry and revenue realization.
Increased Expenses
Rising operational costs, particularly in R&D, can strain financial resources and impact profitability, challenging long-term financial health.
Program Pauses
Pausing clinical trials due to safety concerns can delay product development and affect the company's ability to bring new therapies to market.

uniQure (QURE) vs. SPDR S&P 500 ETF (SPY)

uniQure Business Overview & Revenue Model

Company DescriptionuniQure N.V., a gene therapy company, engages in the development of treatments for patients suffering from genetic and other devastating diseases. Its lead program is Etranacogene dezaparvovec (AMT-061), which is in Phase III HOPE-B pivotal trial for the treatment of hemophilia B. The company also engages in developing AMT-130, a gene therapy that is in Phase I/II clinical study for the treatment of Huntington's disease; AMT-060, which is in Phase I/II clinical trial for the treatment of hemophilia B; AMT-210, a product candidate for the treatment of Parkinson's disease; AMT-260 for temporal lobe epilepsy; AMT-240, a preclinical product candidate for the treatment of autosomal dominant Alzheimer's disease; and AMT-161 for the treatment of amyotrophic lateral sclerosis. uniQure N.V. was founded in 1998 and is headquartered in Amsterdam, the Netherlands.
How the Company Makes MoneyuniQure generates revenue primarily through the sale of its gene therapy products, with significant income derived from its approved treatment for hemophilia B. The company also earns revenue through partnerships and collaborations with other biopharmaceutical companies, which may involve upfront payments, milestone payments based on clinical and regulatory achievements, and royalties on sales of partnered products. Additionally, uniQure may receive funding from government grants or research initiatives aimed at advancing gene therapy technologies, which contribute to its overall financial performance.

uniQure Key Performance Indicators (KPIs)

Any
Any
Revenue by Segment
Revenue by Segment
Highlights income from different business areas, offering insight into which segments drive growth and profitability, and where there might be opportunities or challenges.
Chart InsightsuniQure's revenue from license agreements is showing a gradual recovery, while contract manufacturing revenue has sharply declined to zero in recent quarters. This aligns with the earnings call, which highlighted a significant drop in overall revenue due to reduced collaboration and contract manufacturing. Despite these challenges, uniQure's strong financial position and promising clinical advancements, particularly with AMT-130 for Huntington's disease, suggest a strategic pivot towards high-impact therapeutic developments, potentially offsetting revenue declines in other segments.
Data provided by:The Fly

uniQure Earnings Call Summary

Earnings Call Date:Nov 10, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Mar 02, 2026
Earnings Call Sentiment Neutral
The earnings call showcased significant advancements in uniQure's therapeutic pipeline, particularly for Huntington's disease and epilepsy, despite regulatory challenges and increased operational costs. The financial position remains strong, supporting future operations. However, setbacks with the FDA's stance on AMT-130 and the pause in the AMT-162 program posed challenges.
Q3-2025 Updates
Positive Updates
Positive Top-Line Data for AMT-130 in Huntington's Disease
uniQure announced positive top-line data from their pivotal Phase 1/2 study of AMT-130, showing statistically significant 75% slowing of disease progression at three years compared to a control group. A 60% slowing was observed in a key secondary endpoint.
Financial Growth
uniQure's revenue for Q3 2025 was $3.7 million, up from $2.3 million in Q3 2024, marking an increase of $1.4 million. The increase was due to $1.5 million in license revenues.
Strong Cash Position
uniQure reported cash, cash equivalents, and investment securities totaling $649.2 million as of September 30, 2025, up from $376.5 million at the end of 2024, attributed to net proceeds from public offerings.
Encouraging Initial Data for AMT-260 in Epilepsy
Initial data from AMT-260 for mesial temporal lobe epilepsy showed a promising reduction in seizure frequency with no serious adverse events. Recruitment has expanded following a favorable review.
Fabry Disease Therapy Progress
Phase 1/2a trial of AMT-191 showed encouraging results, with one patient successfully withdrawing from enzyme replacement therapy while maintaining stable levels, indicating potential as a one-time gene therapy.
Negative Updates
FDA Meeting on AMT-130 BLA Submission
The FDA no longer agrees that the Phase 1/2 data of AMT-130 is sufficient for a BLA submission, introducing uncertainty in the timeline for approval.
AMT-162 Program Paused
Enrollment in the Phase 1/2 trial of AMT-162 for SOD1 ALS has been paused due to a dose-limiting toxicity observed in one patient, resulting in a serious adverse event.
Increased Expenses
Research and development expenses increased by $3.8 million, and selling, general, and administrative expenses rose by $7.8 million compared to the same period in 2024, driven by increased employee-related expenses and professional fees.
Company Guidance
During the third quarter of 2025, uniQure N.V. provided key updates on its gene therapy programs. The company announced positive top-line data from its pivotal Phase 1/2 study of AMT-130 for Huntington's disease, demonstrating a 75% slowing of disease progression at three years, as measured by the composite Unified Huntington's Disease Rating Scale (cUHDRS), and a 60% slowing as measured by total functional capacity. Despite these promising results, the FDA expressed concerns about the adequacy of the data for a Biologics License Application (BLA) submission, rendering the timeline uncertain. Additionally, uniQure shared updates on its other pipeline programs, including AMT-260 for mesial temporal lobe epilepsy, which showed promising reductions in seizure frequency, and AMT-191 for Fabry disease, which demonstrated supraphysiological enzyme activity and a manageable safety profile. Financially, the company reported a revenue increase to $3.7 million for the quarter, with research and development expenses rising to $34.4 million, and a strong cash position of $649.2 million as of September 30, 2025.

uniQure Financial Statement Overview

Summary
uniQure faces significant financial challenges, particularly in achieving profitability and positive cash flow. Despite revenue growth, high operating costs prevent net profits. The balance sheet shows some improvement in equity, but the company struggles with negative cash flow and return on equity.
Income Statement
35
Negative
uniQure's income statement shows significant challenges with profitability, as evidenced by negative net profit margins and EBIT margins over the TTM period. Despite a modest revenue growth rate of 9.86% in the TTM, the company has struggled to convert this into profit, with a net profit margin of -14.93%. The gross profit margin is relatively strong at 88.13%, indicating effective cost management at the gross level, but high operating expenses are impacting overall profitability.
Balance Sheet
40
Negative
The balance sheet reflects a moderate debt-to-equity ratio of 0.29, suggesting manageable leverage levels. However, the return on equity is significantly negative at -373.73%, indicating that the company is not generating returns on shareholder equity. The equity ratio is not directly provided, but the company's equity position has improved from negative to positive, indicating some recovery in financial stability.
Cash Flow
30
Negative
Cash flow analysis reveals challenges with negative operating cash flow and free cash flow in the TTM. The free cash flow to net income ratio is slightly above 1, indicating that cash flow is somewhat aligned with net income, albeit both are negative. The free cash flow growth rate is negative, suggesting declining cash generation capabilities.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue15.75M27.12M15.84M106.48M524.00M37.51M
Gross Profit13.88M8.79M2.21M103.14M499.03M-84.89M
EBITDA-146.30M-160.75M-253.10M-108.02M319.00M-126.97M
Net Income-235.15M-239.56M-308.48M-126.79M329.59M-125.02M
Balance Sheet
Total Assets888.38M556.54M831.69M704.96M809.18M340.39M
Cash, Cash Equivalents and Short-Term Investments694.25M367.52M617.89M352.84M556.26M244.93M
Total Debt66.16M66.06M138.41M142.89M135.72M71.54M
Total Liabilities659.64M563.29M624.02M228.96M213.40M96.49M
Stockholders Equity228.75M-6.75M207.67M476.01M595.78M243.91M
Cash Flow
Free Cash Flow-153.62M-186.10M-153.08M-162.75M270.52M-144.31M
Operating Cash Flow-153.24M-182.73M-145.93M-145.06M287.96M-134.83M
Investing Cash Flow93.13M162.97M-205.69M-182.73M-67.39M-9.48M
Financing Cash Flow406.43M-59.49M362.72M1.45M94.86M7.44M

uniQure Technical Analysis

Technical Analysis Sentiment
Negative
Last Price27.63
Price Trends
50DMA
45.25
Negative
100DMA
30.25
Negative
200DMA
21.78
Positive
Market Momentum
MACD
-5.66
Positive
RSI
33.57
Neutral
STOCH
30.69
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For QURE, the sentiment is Negative. The current price of 27.63 is below the 20-day moving average (MA) of 32.80, below the 50-day MA of 45.25, and above the 200-day MA of 21.78, indicating a neutral trend. The MACD of -5.66 indicates Positive momentum. The RSI at 33.57 is Neutral, neither overbought nor oversold. The STOCH value of 30.69 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for QURE.

uniQure Risk Analysis

uniQure disclosed 65 risk factors in its most recent earnings report. uniQure reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

uniQure Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
70
Outperform
$1.23B5.7317.68%-86.40%30.72%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
50
Neutral
$966.18M-30.16%31.11%-46.75%
43
Neutral
$1.70B-165.27%-44.90%11.49%
43
Neutral
$2.31B-32.63%-123.65%
40
Underperform
$986.87M-52.11%33.52%21.66%
40
Underperform
$356.05M-1.46-74.88%18.39%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
QURE
uniQure
27.63
21.66
362.81%
RCKT
Rocket Pharmaceuticals
3.29
-11.10
-77.14%
SYRE
Spyre Therapeutics
29.75
1.32
4.64%
NTLA
Intellia Therapeutics
8.52
-7.10
-45.45%
CVAC
CureVac
5.48
2.61
90.94%
DAWN
Day One Biopharmaceuticals
9.41
-4.52
-32.45%

uniQure Corporate Events

uniQure Reports Q3 2025 Results and Clinical Progress
Nov 11, 2025

uniQure N.V. is a gene therapy company focused on developing transformative treatments for patients with severe medical conditions, operating primarily in the biotechnology sector. In its latest earnings report, uniQure highlighted significant progress in its clinical programs, particularly with its AMT-130 gene therapy for Huntington’s disease, which showed promising results in slowing disease progression. The company also reported advancements in other clinical trials, including AMT-260 for epilepsy and AMT-191 for Fabry disease, with further data expected in 2026.

uniQure N.V. Earnings Call: Pipeline Progress Amid Challenges
Nov 11, 2025

During the recent earnings call, uniQure N.V. presented a mixed sentiment, highlighting significant advancements in its therapeutic pipeline, particularly for Huntington’s disease and epilepsy. Despite these advancements, the company faced regulatory hurdles and increased operational costs. Nevertheless, uniQure’s financial position remains robust, supporting its future operations. However, challenges arose with the FDA’s stance on AMT-130 and the pause in the AMT-162 program.

Product-Related AnnouncementsRegulatory Filings and Compliance
uniQure Faces FDA Setback on Huntington’s Therapy
Negative
Nov 3, 2025

On November 3, 2025, uniQure announced a regulatory update regarding its investigational gene therapy for Huntington’s disease, AMT-130, following a pre-Biologics License Application meeting with the FDA. The company revealed that the FDA no longer agrees that data from Phase I/II studies of AMT-130 in comparison to an external control may be adequate for a BLA submission, creating uncertainty around the timing of the submission. Despite this setback, uniQure is committed to working with the FDA and other regulatory bodies to find a path forward for AMT-130’s approval, emphasizing the therapy’s potential benefits for patients with Huntington’s disease.

The most recent analyst rating on (QURE) stock is a Hold with a $67.00 price target. To see the full list of analyst forecasts on uniQure stock, see the QURE Stock Forecast page.

Business Operations and StrategyProduct-Related Announcements
uniQure Announces Positive Results for Huntington’s Study
Positive
Sep 25, 2025

On September 24, 2025, uniQure announced positive topline results from its pivotal Phase I/II study of AMT-130 for Huntington’s disease, demonstrating a statistically significant 75% slowing of disease progression at 36 months in high-dose patients, compared to a control group. The study met its primary endpoint and showed favorable trends in secondary endpoints, with AMT-130 being well-tolerated and no new serious adverse events reported since December 2022. The company plans to discuss these results with the FDA, aiming for a Biologic License Application submission in early 2026, potentially impacting the treatment landscape for Huntington’s disease.

The most recent analyst rating on (QURE) stock is a Buy with a $76.00 price target. To see the full list of analyst forecasts on uniQure stock, see the QURE Stock Forecast page.

Private Placements and Financing
uniQure Secures $175 Million Loan Amendment
Neutral
Sep 25, 2025

On September 22, 2025, uniQure N.V. entered into an amendment with Hercules Capital to their existing loan agreement, allowing for an additional $175 million in term loans. This amendment is intended to refinance existing loans and support general corporate purposes, potentially impacting uniQure’s financial flexibility and operational capacity in the biotechnology sector.

The most recent analyst rating on (QURE) stock is a Buy with a $76.00 price target. To see the full list of analyst forecasts on uniQure stock, see the QURE Stock Forecast page.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Nov 28, 2025