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- BioMarin Pharmaceutical Inc (NASDAQ:BMRN) has announced new data from GENEr8-1 Phase 3 study for valoctocogene roxaparvovec, investigational gene therapy for severe hemophilia A.
- Data were presented at the International Society on Thrombosis and Haemostasis (ISTH) 2021 Virtual Congress.
- Top-line one-year results from this study were previously communicated in January 2021.
- New data presented include more details on annualized bleeding rate (ABR) in all study participants and annualized Factor VIII utilization rate.
- Over 90% (N=134) of all participants in the GENEr8-1 study had an ABR of zero or a lower bleed rate than baseline after week four after the treatment.
- Mean annualized Factor VIII utilization rate decreased from baseline on Factor VIII prophylaxis by 99% from 3961.2 to 56.9 after week four after treatment with valoctocogene roxaparvovec.
- As previously shared in January 2021, a single dose of valoctocogene roxaparvovec significantly reduced mean ABR by 84% from a prospectively collected 4.8 baseline to 0.8 bleeding episodes per year.
- Study participants also experienced a clinically meaningful increase in endogenous Factor VIII expression.
- Last week, the European Medicines Agency validated BioMarin's resubmission of a marketing application for the gene therapy.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.
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