Protalix Receives Complete Response Letter Regarding BLA For PRX-102 - Quick Facts

(RTTNews) - Protalix BioTherapeutics, Inc. (PLX), and Chiesi Global Rare Diseases said they received a Complete Response Letter from the FDA regarding 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 for PRX-102 included a comprehensive set of preclinical, clinical, and manufacturing data compiled from the completed phase I/II clinical trial of PRX-102.

"While disappointing, we remain confident in the strength of our data and in the depth of our program," said Dror Bashan, Protalix's President and Chief Executive Officer.