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BIOMARIN PHARMACEUTICAL INC.

(BMRN)
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FDA OKs BioMarin's Voxzogo for Children With Most Common Form of Dwarfism

11/19/2021 | 11:00am EST

By Colin Kellaher

The U.S. Food and Drug Administration on Friday said it approved BioMarin Pharmaceutical Inc.'s Voxzogo injection to treat children with the most common form of dwarfism.

The agency said the approval covers Voxzogo to improve growth in children five years of age and older with achondroplasia and open epiphyses, meaning those patients still have the potential to grow.

The FDA said Voxzogo is the first drug approved in the U.S. to treat achondroplasia, a genetic condition that causes severely short stature and disproportionate growth.

The FDA said it gave the green light to Voxzogo under its accelerated approval pathway, which allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need. The agency said it is requiring a post-marketing study assessing final adult height as a condition of the accelerated approval.

BioMarin, a San Rafael, Calif., biotechnology company, in August said the European Commission approved Voxzogo for the treatment of children from the age of two until growth plates are closed, which occurs after puberty when children reach final adult height.

Shares of BioMarin were recently up 5.4% to $87.37.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

11-19-21 1100ET

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Financials (USD)
Sales 2021 1 842 M - -
Net income 2021 -67,5 M - -
Net cash 2021 109 M - -
P/E ratio 2021 -246x
Yield 2021 -
Capitalization 16 564 M 16 564 M -
EV / Sales 2021 8,93x
EV / Sales 2022 7,60x
Nbr of Employees 3 059
Free-Float -
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Mean consensus BUY
Number of Analysts 21
Last Close Price 90,22 $
Average target price 116,10 $
Spread / Average Target 28,7%
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Managers and Directors
Jean-Jacques BienaimÚ Chairman & Chief Executive Officer
Brian R. Mueller Chief Financial Officer & Executive Vice President
Henry J. Fuchs President-Worldwide Research & Development
Eduardo E. von Pervieux Chief Information Officer
Lon Cardon Chief Scientific Strategy Officer
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