Protalix and Chiesi receive positive CHMP opinion for PRX-102 (pegunigalsidase alfa) for Fabry disease

Protalix BioTherapeutics, Inc.

CHMP adopted positive opinion recommending marketing authorization for PRX-102 (pegunigalsidase alfa) for adult Fabry disease patients.
PRX-102 is the first and only pegylated enzyme replacement therapy for Fabry disease.
Clinical program includes Phase 3 BALANCE, BRIDGE, BRIGHT trials with over 400 years of exposure.
Final European Commission decision on MAA expected in early May 2023.
Protalix (PLX) and Chiesi Global Rare Diseases (Chiesi Group) collaboration.

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