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.
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uniQure N.V. (NASDAQ: QURE) will host a virtual Research & Development Day on June 22, 2021, from 8:30 to 11:30 a.m. ET, focusing on its expanding gene therapy pipeline for CNS and liver-directed disorders. The company will also participate in multiple upcoming virtual conferences including the Jefferies Virtual Healthcare Conference (June 1-4), European Hematology Association Virtual 2021 (June 7-13), and Goldman Sachs 42nd Annual Global Healthcare Conference (June 8-11). Notably, results from the pivotal Phase 3 HOPE-B trial will be presented during the EHA conference.
uniQure, a leader in gene therapy, announced its upcoming participation in several virtual investor and scientific conferences, including the Jefferies Virtual Healthcare Conference and the European Hematology Association Virtual 2021. Key highlights include a Research & Development Day on June 22, 2021, focusing on advancements in gene therapy for CNS and rare liver-directed disorders. Additionally, the company will present pivotal data from the HOPE-B trial for etranacogene dezaparvovec targeting hemophilia B.
uniQure has announced the independent Data Safety Monitoring Board (DSMB) has recommended proceeding with the second, higher-dose cohort of its Phase I/II clinical trial for AMT-130, aimed at treating Huntington’s disease. This decision follows a positive review of safety data from the first cohort of ten patients. Moving forward, uniQure plans to enroll patients in the higher-dose cohort and initiate clinical development in Europe later this year. The trial aims to establish the safety and efficacy of AMT-130 in patients with early-stage Huntington's disease.
uniQure presented pivotal Phase III HOPE-B trial data for etranacogene dezaparvovec at the ASGCT Annual Meeting. The study, involving 54 hemophilia B patients, showed that pre-existing neutralizing antibodies (NAbs) to AAV5 did not significantly correlate with FIX activity. Participants with NAbs achieved similar treatment results compared to those without. Notably, 57.4% of subjects had no pre-existing NAbs, and all but one participant achieved stable FIX levels, suggesting etranacogene dezaparvovec could be a viable therapy for a broader patient base.
uniQure N.V. (NASDAQ: QURE) reported its Q1 2021 results, highlighting its advancements in gene therapy for hemophilia B and Huntington's disease. The company closed a $450 million licensing deal with CSL Behring and completed patient enrollment for a Phase I/II trial of AMT-130 for Huntington's. Cash reserves increased to $260.8 million, with funding expected until 2024. However, the net loss rose to $41.6 million, with R&D expenses reaching $32.7 million. Upcoming catalysts include 52-week follow-up data from the HOPE-B trial and a planned R&D Day.
CSL Behring announced the closing of its global commercialization and license agreement with uniQure for etranacogene dezaparvovec (AMT-061), a novel gene therapy for hemophilia B. This agreement follows the completion of antitrust reviews and includes a $450 million upfront payment to uniQure, along with potential milestone payments and royalties. Etranacogene dezaparvovec aims to deliver near-normal levels of Factor IX for patients and could transform treatment for hemophilia B patients. Clinical trials show promise, with no serious treatment-related adverse events reported thus far.
uniQure N.V. has announced that the waiting period for its licensing agreement with CSL Behring for etranacogene dezaparvovec has ended, making the deal effective from May 6, 2021. uniQure will receive a $450 million upfront payment due by May 13, 2021, with potential future payments up to $1.6 billion based on milestones. The agreement includes tiered royalties of up to low-twenties percentage on sales. uniQure remains responsible for the pivotal HOPE-B study and initial manufacturing, while CSL Behring will handle commercialization.
uniQure N.V. (NASDAQ: QURE) announced its participation in three upcoming virtual investor and scientific conferences. The Truist Securities Life Sciences Summit is scheduled for May 4-5, 2021, featuring one-on-one meetings. The American Society of Gene and Cell Therapy (ASGCT) virtual event will take place from May 11-14, 2021, showcasing five data presentations, including two oral presentations on May 12 and 13. Finally, at the RBC Capital Markets Global Healthcare Conference on May 18-19, 2021, there will be additional virtual meetings and a fireside chat with CEO Matt Kapusta.
uniQure N.V. (NASDAQ: QURE) announced five data presentations at the upcoming American Society of Gene and Cell Therapy (ASGCT) Virtual 2021 Annual Meeting from May 11-14. The presentations will focus on gene therapy advancements targeting hemophilia and Huntington’s disease, highlighting the AAV5 vector's efficacy amid pre-existing neutralizing antibodies. Notable sessions include two oral presentations on the Phase 3 HOPE-B trial and miQURE technology's proof-of-concept for liver targeting. These sessions aim to showcase uniQure's innovation in gene therapy for severe medical conditions.
uniQure N.V. (NASDAQ: QURE) has announced that the FDA has lifted the clinical hold on its hemophilia B gene therapy program, following a thorough review regarding a patient who developed hepatocellular carcinoma (HCC) during the HOPE-B trial. Investigations showed no evidence that the therapy contributed to the patient's condition. uniQure is set to release 52-week data from the HOPE-B trial soon. The company has conducted extensive monitoring of patients, with no further HCC cases reported across over 100 participants.
