BioMarin's (BMRN) Vosoritide Gets CHMP Nod to Treat Dwarfism
Zacks Investment Research | Jun 27, 2021 11:18PM ET
BioMarin Pharmaceutical (NASDAQ:BMRN) Inc. industry ’s growth rate of 0.5%.
Meanwhile, in the United States, the new drug application (NDA) for the drug is under priority review with the FDA with a PDUFA target date of November 2021. Once approved, the NDA may even qualify for a Priority Review Voucher. The FDA’s pre-approval inspection of BioMarin’s manufacturing facility of vosoritide drug substance was completed in first-quarter 2021.
The drug has also received a temporary authorization for use in France to begin immediate treatment under an authorized process, since there is no approved treatment for achondroplasia.
Per the company, once approved, vosoritide will become eligible to treat more than 11,000 children affected by achondroplasia across Europe, Middle East and Africa.
BioMarin has heavily invested in the R&D of vosoritide. This increase is on account of redirection of the amount allocated for sales and marketing of other programs to the R&D of vosoritide for supporting pre-commercialization activities related to the drug based on expected approval timelines. Pursuant to vosoritide’s potential approval, the company expects to generate blockbuster sales from the same.
BioMarin currently carries a Zacks Rank #3 (Hold). You can see Zacks Investment Research
Get The News You Want
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.