BioMarin files with EMA for gene therapy for hemophilia A

BioMarin Pharmaceutical (NASDAQ:BMRN) submits a Marketing Authorization Applications to the European Medicines Agency for its investigational gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A.

BioMarin rises 0.5% in after-hours trading.

The company expects the MAA review to commence in January 2020 under accelerated assessment.

 This submission marks the first marketing application submission for a gene therapy product for any type of hemophilia.

The company remains on track to submit a Biologics License Application to the U.S. Food and Drug Administration by the end of the year.

https://seekingalpha.com/news/3521398-biomarin-submits-maa-ema-gene-therapy-hemophilia