LOGO
LOGO

Slide Shows

Biotech Stocks Facing FDA Decision In April 2021

Protalix BioTherapeutics
Protalix BioTherapeutics

Protalix BioTherapeutics Inc. (PLX) has sought accelerated approval of Pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease, and a decision is expected on April 27, 2021.

Fabry disease is an inherited disorder that results from the buildup of a particular type of fat, called globotriaosylceramide, in the body's cells due to deficiency of the enzyme, alpha-galactosidase A (AGA).

Enzyme replacement therapies like Sanofi’s Fabrazyme and Amicus’ Galafold are approved in the U.S. for the treatment of Fabry disease.

Proyalix’s Pegunigalsidase alfa, which is also an enzyme replacement therapy, is a chemically modified version of recombinant alpha-Galactosidase-A protein, administered as an infusion directly into the bloodstream. Pegunigalsidase alfa is manufactured using the company’s ProCellEx plant cell-based protein expression platform.

If approved, Pegunigalsidase alfa could achieve peak sales of $39 million by 2026, according to GlobalData.

PLX closed Friday’s (Mar.26, 2021) trading at $4.83, up 0.84%.