BioMarin Pharma (BMRN) Receives CRL from FDA for Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A

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Go back to BioMarin Pharma (BMRN) Receives CRL from FDA for Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A

BioMarin Receives Complete Response Letter (CRL) from FDA for Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A

August 19, 2020 8:00 AM EDT

SAN RAFAEL, Calif., Aug. 19, 2020 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to the Company's Biologics License Application (BLA) for valoctocogene roxaparvovec gene therapy for severe hemophilia A on August 18, 2020.  The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form.

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