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 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 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 Two-Year Follow-Up Data from the Phase IIb Study of Etranacogene Dezaparvovec and Long-Term Follow-Up Data for AMT-060 in Patients with Hemophilia B
December 07, 2020 16:05 ET
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uniQure Inc.
~ Sustained FIX Activity at Therapeutic Levels1 with a Mean of 44% of Normal at Two Years After Administration of Etranacogene Dezaparvovec in Phase IIb Study ~ ~ Long-term Clinical Benefit and...
uniQure Announces Positive Top-Line Data from the HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B
November 19, 2020 09:10 ET
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uniQure Inc.
~ Phase III study in 54 patients met primary endpoint with mean Factor IX activity of 37% of normal at 26 weeks ~ ~ Patients achieved significant increases in Factor IX activity irrespective of...
uniQure Announces 2019 Financial Results and Highlights Recent Company Progress
March 02, 2020 16:05 ET
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uniQure Inc.
~ Patient Dosing Nearly Completed in Phase III HOPE-B Trial of Etranacogene Dezaparvovecin Hemophilia B ~ ~ First Patient Procedure in Phase I/II Clinical Trial of AMT-130 in Huntington’s Disease...
uniQure Announces Presentations at the Upcoming 13th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD)
February 04, 2020 07:00 ET
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uniQure Inc.
LEXINGTON, Mass. and AMSTERDAM, The Netherlands, Feb. 04, 2020 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with...
uniQure Announces One-Year Follow-Up Data from the Phase IIb Study of Etranacogene Dezaparvovec and Long-Term Follow-Up Data for AMT-060 in Patients with Hemophilia B
December 08, 2019 16:00 ET
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uniQure Inc.
~ Sustained FIX Activity at Therapeutic Levels1 Up to 50% of Normal at One Year After Administration of Etranacogene Dezaparvovec in Phase IIb Study ~ ~ Zero Bleeds and No Requirement for...
uniQure Announces the Allowance of New Patent Providing Further Protection of the Padua and Padua-Related Variants of Factor IX in Gene Therapy
November 05, 2019 07:00 ET
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uniQure Inc.
LEXINGTON, Mass. and AMSTERDAM, the Netherlands, Nov. 05, 2019 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with...