RTTNews | Apr 28, 2021 02:08AM EDT

02:08 Wednesday, April 28, 2021 (RTTNews.com) - 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 (PRX102) for the proposed treatment of adult patients with Fabry disease. The BLA submission for PRX102 included a comprehensive set of preclinical, clinical, and manufacturing data compiled from the completed phase I/II clinical trial of PRX102.

"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.

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