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Stock impact report

Ascendis wins FDA approval of dwarfism drug [Yahoo! Finance]

Ascendis Pharma A/S - American Depositary Shares (ASND) 
Last ascendis pharma a/s - american depositary shares earnings: 11/18 04:01 pm Check Earnings Report
US:NASDAQ Investor Relations: ascendispharma.com
Company Research Source: Yahoo! Finance
This story was originally published on BioPharma Dive . To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter Dive Brief: Ascendis Pharma said Friday the Food and Drug Administration granted accelerated approval to a treatment it's developed for the most common type of dwarfism, ending what had been a monopoly for rival drugmaker BioMarin Pharmaceutical. The new drug, previously known as TransCon CNP and now Yuviwel, is a once-weekly injection cleared for children aged two and older with achondroplasia and open growth plates. The treatment will compete with Voxzogo, a daily shot sold by BioMarin. The accelerated clearance was based on Yuiwel's ability to help spur growth as measured by an evaluation known as “annualized growth velocity,” or AGV. Ascendis needs to confirm those benefits in testing to uphold its approval. The company hasn't yet announced Yuviwel's price, but expects to make the drug available through prescribing physicians in Show less Read more
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