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 N.V. (NASDAQ: QURE) is a gene therapy company that regularly issues news on its clinical programs, regulatory interactions, and financing activities. The company describes itself as delivering single‑treatment gene therapies with potentially curative results and has reported that the approvals of its gene therapy for hemophilia B mark a major milestone in genomic medicine. News about uniQure often highlights progress in its pipeline for Huntington’s disease, refractory temporal lobe epilepsy, ALS, Fabry disease, and other severe conditions.
A major focus of QURE news coverage is AMT‑130, uniQure’s investigational gene therapy for Huntington’s disease. Press releases and related SEC filings detail pivotal Phase I/II trial results, including statistically significant slowing of disease progression at 36 months in high‑dose cohorts compared to a propensity score‑matched external control, as well as trends in motor and cognitive endpoints and biomarker changes. Investors also see updates on the company’s regulatory dialogue with the U.S. Food and Drug Administration, including pre‑BLA and Type A meetings and feedback on the adequacy of Phase I/II data for a potential Biologics License Application.
Beyond AMT‑130, uniQure news includes early‑stage data and enrollment updates for AMT‑260 in refractory mesial temporal lobe epilepsy, AMT‑191 in Fabry disease, and AMT‑162 in SOD1 ALS. Corporate news items cover public offerings of ordinary shares and pre‑funded warrants, amendments to loan facilities, and quarterly financial results. This QURE news page aggregates such disclosures so readers can follow clinical milestones, regulatory developments, and capital markets events that shape uniQure’s gene therapy business over time.
uniQure N.V. (NASDAQ: QURE) announced participation in several upcoming virtual conferences in September 2020. Key events include:
- Citi’s 15th Annual BioPharma Virtual Conference (Sept. 9-10) with a live fireside chat on Sept. 9.
- Baird’s Virtual Global Healthcare Conference (Sept. 9-10) featuring one-on-one investor meetings.
- Wells Fargo Global Healthcare Conference (Sept. 9-10) with a fireside chat on Sept. 10.
- H.C. Wainwright 22nd Annual Global Investment Conference (Sept. 14-15) and Cantor Fitzgerald Virtual Global Healthcare Conference (Sept. 15-17).
- Barclays Boston Biotech Bus Trip (Sept. 23-25).
These events aim to provide insights into uniQure's gene therapy advancements.
uniQure N.V. (NASDAQ: QURE) appointed Ricardo Dolmetsch, Ph.D. as the new President of Research and Development, effective September 14, 2020, succeeding Sander van Deventer, M.D., Ph.D.. Dolmetsch, previously Global Head of Neuroscience at Novartis, brings extensive experience in gene therapy, notably in developing treatments for neurodegenerative diseases. CEO Matt Kapusta praised Dolmetsch's expertise and vision. Under Dolmetsch's leadership, uniQure aims to advance therapies for Huntington’s disease and expand its pipeline. The company plans an extraordinary shareholder meeting in Q4 2020 to re-elect Dr. Robert Gut as a non-executive director.
uniQure N.V. (NASDAQ: QURE) reported significant developments in its Q2 2020 results, including a global licensing agreement with CSL Behring for its hemophilia B gene therapy, potentially worth over $2 billion. The company completed initial dosing in a Phase I/II trial for AMT-130, targeting Huntington’s disease. Financially, uniQure held $314.3 million in cash, expected to fund operations into 2024, despite reporting a net loss of $42.6 million. The revenue declined to $1.5 million, a decrease from $2.5 million year-over-year.
CSL Behring has announced its acquisition of exclusive global rights to AMT-061, a novel gene therapy for hemophilia B from uniQure (QURE). The program, currently in Phase 3 trials, could offer long-term benefits to patients. An upfront payment of US$450 million will be made to uniQure, along with milestone payments and royalties. The therapy aims to restore Factor IX levels in patients, potentially eliminating the need for ongoing treatments. This acquisition supports CSL Behring's commitment to innovative therapies in hemophilia and expands its gene therapy portfolio.
uniQure has entered a licensing agreement with CSL Behring granting exclusive global rights to develop and commercialize etranacogene dezaparvovec, a gene therapy for hemophilia B. uniQure will receive over $2 billion in total, including $450 million upfront and $1.6 billion in milestone payments, along with royalties in the low-twenties percentage range of net sales. This collaboration aims to leverage CSL Behring's global reach to enhance patient access and enable uniQure to accelerate its pipeline, including advancing treatments for Huntington’s disease and Fabry disease.
uniQure (NASDAQ: QURE) announced the treatment of the first two patients in its Phase I/II clinical trial for AMT-130, aimed at Huntington’s disease. This double-blind study, involving 26 patients, will assess safety, tolerability, and efficacy signals. One patient received AMT-130 while the other underwent sham surgery. The trial features an 18-month core study followed by long-term follow-ups. The innovative delivery method involves MRI-guided surgery. This milestone reflects uniQure's commitment to developing effective therapies for Huntington’s disease, a condition with no currently approved treatments.
uniQure N.V. has appointed Leonard E. Post, Ph.D., to its Board of Directors, enhancing its research leadership. Dr. Post, with over 35 years in biotechnology, will also chair the Research & Development Committee. His past roles include significant positions at BioMarin and Onyx Pharmaceuticals, focusing on gene therapy. This strategic move aims to bolster uniQure's pipeline, particularly in preparing for marketing authorization of etranacogene dezaparvovec for hemophilia B. This leadership change reflects a commitment to advancing innovative therapies for severe medical conditions.
uniQure N.V. (NASDAQ: QURE) announced a virtual format for its 2020 Annual General Meeting on June 17, 2020, due to COVID-19 concerns. Shareholders of record as of May 20, 2020, can participate via a virtual meeting platform but cannot vote in real-time or attend in person. The meeting’s details can be accessed through the uniQure website. The company is focused on advancing gene therapy treatments for severe genetic diseases, including hemophilia and Huntington’s disease.
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