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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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.