uniQure (NASDAQ:QURE – Get Free Report) issued its quarterly earnings data on Wednesday. The biotechnology company reported ($0.88) EPS for the quarter, topping the consensus estimate of ($0.92) by $0.04, FiscalAI reports. The firm had revenue of $5.20 million for the quarter, compared to analyst estimates of $6.17 million. uniQure had a negative net margin of 1,154.84% and a negative return on equity of 96.34%.
Here are the key takeaways from uniQure’s conference call:
- The FDA accepted uniQure’s BLA for AMT-130 and granted Priority Review, setting a target decision date of May 1, 2027; the U.K. regulator also validated the company’s marketing application. The FDA is tentatively planning an advisory committee discussion, but approval is not assured.
- Management highlighted prior AMT-130 results showing a reported 75% slowing of disease progression on cUHDRS and 60% on Total Functional Capacity at 36 months versus a matched external control. The company also cited follow-up through 48 months, while noting the evidence comes from a small number of patients.
- The planned confirmatory study will enroll about 200 patients, randomize them 2:1 to AMT-130 or standard of care, and assess TFC at 36 months; screening is expected to begin by year-end. UniQure says it is preparing to have the study well underway by a potential approval, while planning for possible control-arm dropouts and global recruitment.
- Launch preparations are focused on specialist centers, with the company targeting more than 15 operational centers at launch but not yet specifying patient capacity. Management identified center readiness, institutional approvals and payer access as potential factors affecting how quickly patients could receive treatment.
- Cash, cash equivalents and investments totaled $768.4 million at quarter-end, and management expects funding to last into 2030. SG&A increased year over year amid hiring and launch preparations; separately, the company expects updated AMT-260 epilepsy and AMT-191 Fabry data in the first half of 2027.
uniQure Stock Up 3.7%
Shares of uniQure stock traded up $0.78 on Friday, reaching $21.79. 622,832 shares of the company were exchanged, compared to its average volume of 2,419,052. The stock’s 50 day moving average price is $32.42 and its 200-day moving average price is $29.68. The company has a debt-to-equity ratio of 0.17, a current ratio of 11.52 and a quick ratio of 10.01. uniQure has a 1-year low of $8.73 and a 1-year high of $51.72. The company has a market cap of $1.51 billion, a P/E ratio of -6.21 and a beta of 1.14.
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uniQure Company Profile
uniQure N.V. is a biotechnology company focused on developing gene therapies for serious and life-threatening diseases. The company uses adeno-associated virus (AAV) vectors and other genetic medicine technologies to deliver therapeutic genes intended to address the underlying causes of disease.
uniQure’s best-known product is HEMGENIX, a gene therapy for adults with hemophilia B caused by factor IX deficiency. HEMGENIX was developed by uniQure and is commercialized by CSL Behring under a global licensing agreement.
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