Benzinga | Jul 15, 2021 09:39AM EDT

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

* 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.