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BioMarin Submits Biologics License Application To FDA For Valoctocogene Roxaparvovec To Treat Hemophilia A

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) announced today that the company submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its investigational AAV gene therapy,

Benzinga · 12/23/2019 13:45

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) announced today that the company submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its investigational AAV gene therapy, valoctocogene roxaparvovec, for adults with hemophilia A.  Subject to completion of the FDA's filing review, BioMarin anticipates the BLA review to commence in February 2020.  BioMarin will provide an update in February 2020.