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uniQure Announces FDA Removes Clinical Hold On Hemophilia B Gene Therapy Program


Benzinga | Apr 26, 2021 07:08AM EDT

uniQure Announces FDA Removes Clinical Hold On Hemophilia B Gene Therapy Program

uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, announced today that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on the Company's hemophilia B gene therapy program after determining the Company satisfactorily addressed all issues identified by the FDA related to a single patient diagnosed with hepatocellular carcinoma (HCC) in the HOPE-B pivotal trial.






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