Biomarin Could Possibly Be The First To Obtain FDA Approval For Hemophilia Gene Therapy Treatment [Seeking Alpha]
BioMarin Pharmaceutical Inc. (BMRN)
Last biomarin pharmaceutical inc. earnings: 4/29 04:01 pm
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Source: Seeking Alpha
SummaryBiomarin had its BLA accepted by the FDA for its gene therapy valoctocogene roxaparvovec which is being used to treat patients with severe Hemophilia A.The entire Hemophilia market is estimated to be worth $16.84 billion by 2026, However, Hemophilia A accounts for 80% of all Hemophilia cases.The PDUFA date for FDA review of valoctocogene roxaparvovec for severe Hemophilia A is set for August 21, 2020; For the time being there is no plan for advisory panel.Biomarin has a chance to obtain regulatory approval in Europe for valoctocogene roxaparvovec; The EMA had already accepted the application and is currently under review.BMRNBiologics License Application (BLA) accepted by the FDAAccepted BLA Moves Company Forward In Large MarketThe BLA being accepted for valoctocogene roxaparvovec (valrox) set an FDA first. Another good thing to come out of it would be the first gene therapy to be approved for the treatment of patients with Hemophilia A. Hemophilia A is a Factor VIII (FVIII) de
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BMRN
News
- CAMP4 Reports Third Quarter 2024 Financial Results [Yahoo! Finance]Yahoo! Finance
- Here's Why BioMarin Pharmaceutical (BMRN) is a Strong Growth Stock [Yahoo! Finance]Yahoo! Finance
- BioMarin Pharmaceutical Inc. (BMRN): Among the Best Genomics Stocks to Buy Right Now [Yahoo! Finance]Yahoo! Finance
- BioMarin Presents Real-World Evidence Further Supporting Safety and Efficacy of VOXZOGO® (vosoritide) in Children with Achondroplasia at the European Society for Paediatric Endocrinology (ESPE) Meeting 2024 [Yahoo! Finance]Yahoo! Finance
- BioMarin Presents Real-World Evidence Further Supporting Safety and Efficacy of VOXZOGO® (vosoritide) in Children with Achondroplasia at the European Society for Paediatric Endocrinology (ESPE) Meeting 2024PR Newswire
BMRN
Earnings
- 10/29/24 - Beat
BMRN
Sec Filings
- 11/14/24 - Form 4
- 11/12/24 - Form 144
- 10/31/24 - Form 10-Q
- BMRN's page on the SEC website