uniQure (NASDAQ:QURE) Posts Quarterly Earnings Results

uniQure (NASDAQ:QURE) posted its quarterly earnings results on Monday. The biotechnology company reported ($0.56) earnings per share for the quarter, beating analysts’ consensus estimates of ($0.93) by $0.37, FiscalAI reports. uniQure had a negative return on equity of 373.73% and a negative net margin of 1,492.90%.The company had revenue of $5.57 million for the quarter, compared to the consensus estimate of $4.84 million.

Here are the key takeaways from uniQure’s conference call:

• The FDA told uniQure the Phase I/II AMT-130 data compared to external controls are unlikely to be sufficient for a BLA and “strongly recommended” a randomized, double‑blind sham‑surgery‑controlled Phase III; uniQure plans a Type B meeting in Q2 2026 and will update the SAP to include a 4‑year analysis (expected Q3 2026) while continuing regulatory dialogue.
• uniQure highlighted its landmark 3‑year Phase I/II results for AMT‑130 showing ~75% slowing on the composite HD scale, ~60% slowing on Total Functional Capacity, and reductions in NfL versus an Enroll‑HD external comparator and says it remains confident in the data’s durability.
• The company is pursuing ex‑U.S. regulatory discussions (EMA, MHRA and others) and evaluating named‑patient/early‑access pathways and market priorities to potentially bring AMT‑130 to patients outside the U.S.
• In Fabry, AMT‑191 produced dose‑dependent, durable alpha‑Gal A increases and all 11 patients have stopped enzyme replacement, but dosing at mid and high doses is paused after two asymptomatic grade‑3 liver enzyme elevations were confirmed as dose‑limiting (patients are improving on steroids).
• uniQure ended 2025 with $622.5 million in cash, cash equivalents and investments and says this balance sheet supports operations into the second half of 2029.

uniQure Stock Down 32.8%

Shares of uniQure stock opened at $10.50 on Tuesday. The firm has a market cap of $654.05 million, a PE ratio of -2.39 and a beta of 0.73. The business’s 50 day simple moving average is $23.17 and its 200 day simple moving average is $29.77. The company has a debt-to-equity ratio of 0.23, a quick ratio of 7.12 and a current ratio of 7.12. uniQure has a 52-week low of $7.76 and a 52-week high of $71.50.

Wall Street Analyst Weigh In

A number of brokerages have recently commented on QURE. Sanford C. Bernstein cut uniQure to a “market perform” rating in a research note on Tuesday. Wall Street Zen lowered shares of uniQure from a “hold” rating to a “sell” rating in a report on Sunday, January 11th. Wells Fargo & Company reissued an “equal weight” rating and issued a $15.00 price target (down from $60.00) on shares of uniQure in a report on Tuesday. Royal Bank Of Canada downgraded uniQure from a “moderate buy” rating to a “hold” rating and set a $11.00 price objective on the stock. in a research note on Monday. Finally, Cantor Fitzgerald reissued a “neutral” rating and issued a $9.00 target price (down from $55.00) on shares of uniQure in a research note on Monday. Seven investment analysts have rated the stock with a Buy rating, nine have assigned a Hold rating and one has given a Sell rating to the company’s stock. According to MarketBeat.com, uniQure presently has a consensus rating of “Hold” and an average price target of $36.75.

Insider Buying and Selling at uniQure

In related news, Director Jack Kaye sold 6,390 shares of the stock in a transaction on Friday, January 9th. The shares were sold at an average price of $27.28, for a total transaction of $174,319.20. Following the completion of the transaction, the director owned 20,439 shares in the company, valued at approximately $557,575.92. This represents a 23.82% decrease in their ownership of the stock. The sale was disclosed in a document filed with the SEC, which can be accessed through this hyperlink. Also, CEO Matthew C. Kapusta sold 12,378 shares of the stock in a transaction on Wednesday, February 25th. The stock was sold at an average price of $23.86, for a total transaction of $295,339.08. Following the transaction, the chief executive officer owned 639,076 shares of the company’s stock, valued at $15,248,353.36. The trade was a 1.90% decrease in their position. The SEC filing for this sale provides additional information. Insiders have sold 50,598 shares of company stock valued at $1,248,588 over the last ninety days. 4.79% of the stock is currently owned by company insiders.

Institutional Trading of uniQure

Several institutional investors and hedge funds have recently added to or reduced their stakes in QURE. Corient Private Wealth LLC lifted its holdings in shares of uniQure by 100.0% during the second quarter. Corient Private Wealth LLC now owns 21,260 shares of the biotechnology company’s stock worth $296,000 after buying an additional 10,630 shares in the last quarter. Vontobel Holding Ltd. bought a new position in uniQure during the fourth quarter worth about $286,000. Financial Engines Advisors L.L.C. acquired a new stake in uniQure in the 3rd quarter worth about $278,000. Creative Planning bought a new stake in uniQure in the 3rd quarter valued at about $276,000. Finally, Orion Porfolio Solutions LLC acquired a new position in shares of uniQure during the 4th quarter worth approximately $258,000. 78.83% of the stock is owned by institutional investors.

uniQure News Roundup

Here are the key news stories impacting uniQure this week:

• Positive Sentiment: Q4 / FY‑2025 results: uniQure reported quarterly results that showed a narrower-than-expected loss per share and company commentary on program progress, providing a modest fundamental positive amid the broader selloff. uniQure 2025 Financial Results
• Neutral Sentiment: uniQure notes it will pursue follow‑up regulatory engagement (plans to request a Type B meeting in Q2 2026) as it evaluates Phase III paths for AMT‑130 — this keeps the program alive but creates timing and cost uncertainty. uniQure Announces 2025 Financial Results and Provides Recent Company Updates
• Neutral Sentiment: Corporate governance risk: uniQure disclosed it will fall under the Dutch “large company” regime in 2026, which may reduce direct shareholder control over board appointments — a governance risk that could affect investor sentiment but not near‑term operations. uniQure Faces 2026 Shift to Dutch Large Company Regime
• Negative Sentiment: FDA setback for AMT‑130: the FDA told uniQure that existing trial data are insufficient to support approval and recommended a randomized, sham‑controlled Phase III study for the Huntington’s gene therapy — a major regulatory hurdle that prompted a sharp share decline. This increases development time, cost, and approval risk. FDA tells UniQure study data insufficient for brain disorder therapy application
• Negative Sentiment: Market reaction and coverage: multiple reports note QURE shares plunged heavily after the FDA guidance, amplifying volatility and raising the bar for recovery. UniQure shares crash 40% as FDA rejects early approval path for Huntington’s gene therapy
• Negative Sentiment: Analyst downgrades / lower price targets: Cantor Fitzgerald reaffirmed a “Neutral” rating with a steeply reduced $9 target and Royal Bank of Canada cut uniQure to “Sector Perform” with an $11 target — both moves signal diminished near‑term upside in analyst views. uniQure Downgraded by Royal Bank Of Canada
• Negative Sentiment: Multiple securities class‑action filings and reminders: several law firms have filed or are soliciting lead‑plaintiff investors over prior disclosures, increasing potential legal exposure and heightening selling pressure. uniQure N.V. Sued for Securities Law Violations

About uniQure

uniQure N.V. is a biotechnology company focused on the development and commercialization of gene therapies for patients with severe medical needs. Using its proprietary adeno‐associated viral (AAV) vector platform, the company designs single‐dose treatments aimed at addressing the underlying genetic causes of disease rather than solely managing symptoms. Its most advanced program, Hemgenix® (etranacogene dezaparvovec), received regulatory approval in the United States and Europe for adult patients with hemophilia B, marking one of the first gene therapies for a bleeding disorder to reach the market.

Beyond hemophilia B, uniQure’s pipeline includes preclinical and clinical-stage candidates targeting rare and debilitating conditions such as aromatic l-amino acid decarboxylase (AADC) deficiency, Huntington’s disease, and Parkinson’s disease.