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Uniqure Stock Price, News & Analysis

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Welcome to our dedicated page for Uniqure news (Ticker: QURE), a resource for investors and traders seeking the latest updates and insights on Uniqure stock.

uniQure (QURE) is a leading biotechnology company advancing innovative gene therapies for severe genetic diseases, including hemophilia and Huntington's disease. This dedicated news hub provides investors and stakeholders with timely updates on clinical developments, regulatory milestones, and strategic partnerships.

Access the most comprehensive collection of official press releases, clinical trial progress reports, and financial disclosures directly impacting QURE's trajectory. Our curated feed ensures you never miss critical updates about therapeutic advancements or collaborative ventures with industry leaders like Bristol Myers Squibb.

This resource serves investors seeking material events analysis, researchers tracking gene therapy innovations, and healthcare professionals monitoring treatment breakthroughs. All content is sourced from verified channels to maintain accuracy and compliance with financial reporting standards.

Bookmark this page for streamlined access to uniQure's latest announcements. Check back regularly for real-time updates on one of biotech's most dynamic gene therapy innovators.

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CSL announced pivotal HOPE-B trial results for HEMGENIX® (etranacogene dezaparvovec-drlb), the first gene therapy approved for adult hemophilia B patients, showing significant long-term efficacy and safety. Published in NEJM, the trial demonstrated a 71% reduction in spontaneous bleeding episodes and a 78% reduction in joint bleeding episodes. Post-treatment, 96.3% of patients discontinued factor IX prophylaxis after 18 months, with infusions dropping from 72.5 to 2.5 annually. HEMGENIX® is now approved in the US and EU, showcasing CSL's commitment to innovative treatments for rare diseases.

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uniQure N.V. (NASDAQ: QURE) announced that its partner CSL has received conditional marketing authorization from the European Commission for HEMGENIX® (etranacogene dezaparvovec), the first gene therapy for severe and moderately severe hemophilia B in the European Union. This approval is significant as it marks a major milestone in genomic medicine, allowing eligible patients to produce their own factor IX, thereby reducing annual bleeding rates and eliminating the need for routine factor IX infusions. The HOPE-B clinical trial showed a 64% reduction in adjusted annualized bleed rates, with 96% of patients discontinuing prophylaxis. uniQure stands to receive significant milestone payments and royalties as part of its agreement with CSL.

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The European Commission has granted conditional marketing authorization for HEMGENIX® (etranacogene dezaparvovec), marking it as the first one-time gene therapy for treating severe hemophilia B in adults. The therapy showed a 64% reduction in the adjusted annualized bleed rate in patients during clinical trials. Following the pivotal HOPE-B trial, 96% of patients discontinued routine Factor IX prophylaxis, with a 97% reduction in Factor IX consumption. The approval reflects CSL's commitment to innovation and improving the quality of life for hemophilia B patients.

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uniQure (NASDAQ: QURE) has entered into a global licensing agreement with Apic Bio for APB-102, a gene therapy aimed at treating SOD1 amyotrophic lateral sclerosis (ALS). This agreement enhances uniQure's pipeline of innovative gene therapies. APB-102 has FDA clearance for an investigational new drug (IND) application and received Orphan Drug and Fast Track designations. The therapy is a one-time treatment designed to reduce SOD1 expression and potentially reverse ALS progression. uniQure plans to start a Phase I/II trial of APB-102 in the latter half of 2023, with an initial payment of $10 million and additional milestone payments up to $45 million.

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uniQure N.V. (NASDAQ: QURE) announced the granting of equity awards to 24 employees, totaling 40,000 restricted stock units (RSUs) and options for 26,000 ordinary shares on December 7, 2022. This follows additional grants made on October 31 and September 27, 2022. The options have exercise prices of $23.73, $18.62, and $18.04, respectively, based on closing prices on the grant dates. The options will vest over four years, while RSUs will vest over three years. These awards serve as inducements for new hires, emphasizing the company's growth strategy.

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uniQure N.V. has announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its gene therapy, etranacogene dezaparvovec, aimed at treating hemophilia B. If approved, it will be the first licensed gene therapy for this condition in Europe. The therapy has shown a 64% reduction in annual bleeds and allows 96% of patients to discontinue routine prophylaxis. The therapy is already approved in the U.S. and is produced by uniQure for its commercial partner, CSL.

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CSL announced significant findings from the 24-month follow-up of the pivotal HOPE-B study for HEMGENIX, the first gene therapy approved for hemophilia B. The treatment resulted in sustained mean factor IX activity levels (36.7 IU/dL) and a 64% reduction in bleeding rates (ABR) among participants. Safety data indicated no serious treatment-related adverse effects. With 94% of patients discontinuing prophylaxis, HEMGENIX shows promise for long-term efficacy and safety in hemophilia B treatment, highlighting CSL's commitment to innovative therapies.

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uniQure (NASDAQ: QURE) recently hosted a virtual investor event highlighting its gene therapy AMT-260, targeting refractory temporal lobe epilepsy. The event included insights from leading clinical experts and showcased promising preclinical data indicating AMT-260's efficacy and safety. The company plans to submit an investigational new drug application for AMT-260 and initiate clinical development in 2023. Additionally, uniQure reported advancements in its manufacturing platform, enhancing efficiency and reducing costs for AAV therapies.

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uniQure N.V. announced the FDA's approval of HEMGENIX® (etranacogene dezaparvovec-drlb), a groundbreaking gene therapy for hemophilia B. This one-time treatment offers significant benefits, including a reduction in annual bleeding rates and discontinuation of prophylactic therapy for 94% of trial participants. Developed through a comprehensive clinical program, HEMGENIX enables patients to produce their own factor IX, improving their quality of life. uniQure will supply CSL for commercialization, having received $500 million in payments and potential future royalties valued at up to $1.5 billion.

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The FDA has approved HEMGENIX (etranacogene dezaparvovec-drlb), the first one-time gene therapy for adults with hemophilia B, allowing eligible patients to produce their own factor IX. This treatment reduces the frequency of annual bleeding episodes and eliminates the need for prophylactic therapies. In the pivotal HOPE-B trial, 94% of patients discontinued factor IX prophylaxis post-treatment, with a 54% reduction in the annualized bleeding rate. HEMGENIX represents a significant advancement in hemophilia B treatment, enhancing patient outcomes with a single infusion.

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FAQ

What is the current stock price of Uniqure (QURE)?

The current stock price of Uniqure (QURE) is $14.4 as of July 11, 2025.

What is the market cap of Uniqure (QURE)?

The market cap of Uniqure (QURE) is approximately 789.5M.
Uniqure

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QURE Stock Data

789.47M
50.96M
8.59%
77.63%
4.75%
Biotechnology
Pharmaceutical Preparations
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Netherlands
AMSTERDAM