uniQure (NASDAQ:QURE) Releases Earnings Results, Beats Estimates By $0.37 EPS

uniQure (NASDAQ:QURE) posted its quarterly earnings results on Monday. The biotechnology company reported ($0.56) earnings per share for the quarter, beating the consensus estimate of ($0.93) by $0.37, FiscalAI reports. The firm had revenue of $5.57 million for the quarter, compared to analyst estimates of $4.84 million. uniQure had a negative return on equity of 230.98% and a negative net margin of 1,236.00%.

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 Price Performance

Shares of uniQure stock opened at $9.03 on Wednesday. The company has a current ratio of 7.12, a quick ratio of 7.12 and a debt-to-equity ratio of 0.23. The firm has a fifty day simple moving average of $22.86 and a 200-day simple moving average of $29.72. The stock has a market capitalization of $562.48 million, a price-to-earnings ratio of -2.62 and a beta of 0.73. uniQure has a 1-year low of $7.76 and a 1-year high of $71.50.

Analyst Ratings Changes

Several equities analysts have weighed in on the company. Sanford C. Bernstein cut uniQure to a “market perform” rating in a research note on Tuesday. Wolfe Research initiated coverage on shares of uniQure in a research report on Monday, February 23rd. They set a “peer perform” rating on the stock. Weiss Ratings reiterated a “sell (d-)” rating on shares of uniQure in a research note on Wednesday, January 21st. Stifel Nicolaus set a $14.00 target price on shares of uniQure in a research note on Monday. Finally, Cantor Fitzgerald reaffirmed a “neutral” rating and issued a $9.00 price target (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 issued a Hold rating and one has assigned a Sell rating to the company’s stock. Based on data from MarketBeat, uniQure has a consensus rating of “Hold” and a consensus target price of $34.33.

Key Headlines Impacting uniQure

Here are the key news stories impacting uniQure this week:

• Positive Sentiment: Q4 results beat EPS estimates (reported loss narrower than expected) and revenue slightly exceeded consensus — a bright spot that underpinned short‑term investor interest. uniQure Q4 2025 press release
• Neutral Sentiment: uniQure says it will request a follow‑up Type B meeting with the FDA and is evaluating Phase III options for AMT‑130; this keeps development optionality but delays any near‑term approval path. Company update
• Neutral Sentiment: Unusually high trading volume was reported after the earnings/FDA news — increases liquidity but also signals heavy repositioning by investors. Volume report
• Negative Sentiment: Regulatory setback: the FDA told uniQure that existing trial data for AMT‑130 are insufficient for a marketing application and recommended a randomized sham‑controlled Phase III — the market viewed this as a major setback for the Huntington’s program. Reuters: FDA tells uniQure study data insufficient
• Negative Sentiment: Analyst downgrades and price‑target cuts followed the FDA news — notable moves include Goldman Sachs cutting its target dramatically to $9 (neutral), Wells Fargo downgrading from strong‑buy to hold (equal‑weight), and several firms trimming targets and forecasts, removing near‑term upside. Wells Fargo rating note
• Negative Sentiment: Multiple securities‑class action notices and law‑firm solicitations have been filed/announced alleging investor harm tied to disclosures about AMT‑130, adding legal risk and potential distraction/cost. Pomerantz class action notice

Insider Activity

In other uniQure news, Director Robert Gut sold 25,613 shares of the company’s stock in a transaction on Monday, January 12th. The stock was sold at an average price of $24.62, for a total value of $630,592.06. Following the sale, the director directly owned 32,342 shares in the company, valued at $796,260.04. This represents a 44.19% decrease in their ownership of the stock. The sale was disclosed in a legal filing with the SEC, which is available at this hyperlink. Also, CEO Matthew C. Kapusta sold 12,378 shares of uniQure stock in a transaction on Wednesday, February 25th. The shares were sold at an average price of $23.86, for a total value of $295,339.08. Following the transaction, the chief executive officer directly owned 639,076 shares of the company’s stock, valued at approximately $15,248,353.36. The trade was a 1.90% decrease in their ownership of the stock. The SEC filing for this sale provides additional information. Over the last quarter, insiders have sold 50,598 shares of company stock worth $1,248,588. Insiders own 4.79% of the company’s stock.

Institutional Trading of uniQure

Large investors have recently added to or reduced their stakes in the company. Woodline Partners LP raised its stake in shares of uniQure by 25.0% in the first quarter. Woodline Partners LP now owns 175,806 shares of the biotechnology company’s stock valued at $1,864,000 after acquiring an additional 35,175 shares during the last quarter. Legal & General Group Plc bought a new position in uniQure in the 2nd quarter valued at $497,000. Marshall Wace LLP boosted its stake in uniQure by 276.5% in the second quarter. Marshall Wace LLP now owns 222,979 shares of the biotechnology company’s stock worth $3,108,000 after purchasing an additional 163,749 shares in the last quarter. California State Teachers Retirement System bought a new stake in shares of uniQure during the second quarter worth $540,000. Finally, Ameriprise Financial Inc. increased its stake in shares of uniQure by 38.6% in the second quarter. Ameriprise Financial Inc. now owns 761,948 shares of the biotechnology company’s stock valued at $10,622,000 after buying an additional 212,218 shares in the last quarter. 78.83% of the stock is owned by institutional investors.

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.