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BioMarin Expects EMA's CHMP Opinion In 1H 2022 For Its Hemophilia A Gene Therapy, FDA Resubmission In 2Q'22

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  • The European Medicines Agency (EMA) has validated BioMarin Pharmaceutical Inc's (NASDAQ: BMRN) marketing application seeking approval for hemophilia A gene therapy, valoctocogene roxaparvovec.

  • With today's validation, the application review can now commence. A CHMP opinion is anticipated in the first half of 2022.

  • BioMarin resubmitted the European marketing application in June.

  • In the U.S., BioMarin intends to submit two-year follow-up safety and efficacy data on all study participants from the Phase 3 GENEr8-1 study to support the benefit/risk assessment of valoctocogene roxaparvovec, as previously requested by the FDA.

  • BioMarin targets an application resubmission in Q2 of 2022, assuming favorable study results, followed by an expected six-month review by the FDA.

  • Price Action: BMRN shares are down 1.21% at $78.72 during the market session on the last check Thursday.

  • Related content: Benzinga's Full FDA Calendar.

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