BioMarin Delays Resubmission, But Roctavian’s Rocky Road Winding Down

FDA Request Means Company Expects BLA By End Of September

The company had planned to refile its application at the end of June, though it is gearing up for potential approval and commercialization in Europe that could provide important experience for the US.

BioMarin said it would refile Roctavian by the end of September • Source: Shutterstock

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