uniQure announces positive CHMP opinion for etranacogene dezaparvovec – gene therapy for adults with hemophilia B
December 16, 2022 07:15 ET
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uniQure Inc.
LEXINGTON, Mass. and AMSTERDAM, Dec. 16, 2022 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical...
uniQure announces FDA approval of first gene therapy for adults with hemophilia B
November 22, 2022 16:40 ET
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uniQure Inc.
~ Historic approval provides a new treatment option that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy, and generates elevated and sustained factor IX...
uniQure Announces FDA Acceptance of Biologics License Application for Etranacogene Dezaparvovec under Priority Review
May 24, 2022 08:00 ET
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uniQure Inc.
LEXINGTON, Mass. and AMSTERDAM, May 24, 2022 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical...
uniQure and CSL Behring Announce Primary Endpoint Achieved in HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B
December 09, 2021 07:05 ET
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uniQure Inc.
~ Largest gene therapy study in hemophilia B achieved primary endpoint of non-inferiority in annualized bleeding rate after stable Factor IX (FIX) expression, assessed at 18 months following a single...
uniQure Announces Positive 52-Week Clinical Data from HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B and Provides Regulatory Update
June 22, 2021 11:31 ET
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uniQure Inc.
~ Sustained increases in Factor IX (FIX) levels with mean FIX activity of 41.5 percent of normal in full study population one year following a single administration of etranacogene dezaparvovec ~ ~...
uniQure Presents HOPE-B Clinical Data Demonstrating Clinical Benefit in Hemophilia B Patients with Pre-existing Antibodies to AAV5 Vector
May 13, 2021 07:00 ET
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uniQure Inc.
~ Data Show No Clinically Significant Correlation Between Pre-Existing NAbs and FIX Activity ~ ~ Further Supports Potential for AAV5 Gene Therapies to be Viable Treatments in Nearly All Patients -- ...
uniQure announces closing of commercialization and license agreement with CSL Behring
May 06, 2021 07:00 ET
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uniQure Inc.
LEXINGTON, Mass. and AMSTERDAM, May 06, 2021 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical...
uniQure Announces FDA Removes Clinical Hold on Hemophilia B Gene Therapy Program
April 26, 2021 07:05 ET
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uniQure Inc.
LEXINGTON, Mass. and AMSTERDAM, The Netherlands, April 26, 2021 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with...
uniQure Announces Findings from Reported Case of Hepatocellular Carcinoma (HCC) in Hemophilia B Gene Therapy Program
March 29, 2021 07:05 ET
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uniQure Inc.
~ Independent investigation shows that etranacogene dezaparvovec is highly unlikely to be the causeof HCC in HOPE-B pivotal trial ~ ~ Data from investigation submitted to U.S Food and Drug...
uniQure Announces Multiple Presentations and Investor Webcast on Hemophilia B Gene Therapy Program at the 62nd American Society of Hematology (ASH) Annual Meeting
November 30, 2020 07:05 ET
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uniQure Inc.
~ Strong Presence at ASH Featuring Five Presentations, Including Late-BreakingOral Presentation on HOPE-B Pivotal Trial ~ ~ uniQure to Host Investor Webcast Tuesday, December 8, 2020 at 5:00 p.m. ET...