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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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