uniQure N.V.

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Products, Regulatory

Uniqure Announces Clinical Update On Hemophilia B Gene Therapy Program

Published: 12/21/2020 12:17 GMT
uniQure N.V. (QURE) - Uniqure Announces Clinical Update on Hemophilia B Gene Therapy Program.
Uniqure NV - Hemophilia B Gene Therapy Program, Including Pivotal, Phase Iii Hope-b Study, Has Been Placed on Clinical Hold by FDA.
Uniqure NV - Clinical Hold Was Initiated Following Submission of a Safety Report in Mid-december Relating to a Possibly Related Serious Adverse Event.
Uniqure - Working Closely With FDA, Advisors to Conduct Thorough Investigation Into Cause of Event Which We Expect to Be Completed in Early 2021.
Uniqure - Do Not Anticipate Any Impact to Regulatory Submission Timeline for Hemophilia B Program As a Result of Clinical Hold.