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Protalix: FDA Extends PDUFA Action Date For Pegunigalsidase Alfa - Quick Facts

Protalix BioTherapeutics, Inc. (PLX) and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., announced the FDA has extended the PDUFA date for review of the Biologics License Application seeking accelerated approval of pegunigalsidase alfa (PRX-102) for the proposed treatment of adult patients with Fabry disease. The BLA submission includes a set of preclinical, clinical, and manufacturing data compiled from the phase I/II clinical trial of pegunigalsidase alfa.

The FDA extended the PDUFA action date by three months to April 27, 2021, from January 27, 2021.

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