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.
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April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.