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Biotech Stocks Facing FDA Decision In November 2021

BioMarin
BioMarin

The FDA decision on BioMarin Pharmaceutical Inc.’s (BMRN) Vosoritide, proposed for the treatment of children with achondroplasia, is expected on Nov.20, 2021.

Achondroplasia, the most common form of disproportionate short stature in humans, is caused by a mutation in fibroblast growth factor receptor 3 gene (FGFR3), a negative regulator of bone growth.

Vosoritide was approved under brand name VOXZOGO by the European Commission as recently as Aug.21, 2021, to treat achondroplasia in children, becoming the first approved drug for this condition in Europe.

Voxzogo, a once daily injection, is a modified C-type natriuretic peptide (CNP) that directly targets the underlying pathophysiology of achondroplasia by down regulating fibroblast growth factor receptor 3 (FGFR3) signaling and consequently promoting endochondral bone formation.

According to analysts, Voxzogo could bring in peak sales of over $500 million to $1 billion.

BMRN closed Thursday’s trading at $78.20, up 9.04%.