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Stock impact report

Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce Validation of Variation Submission by European Medicines Agency for pegunigalsidase alfa

Protalix BioTherapeutics, Inc. (DE) (PLX) 
Company Research Source: PR Newswire
- Application to label a less frequent dosing regimen at a dose of 2 mg/kg body weight administered every four weeks in adult patients with Fabry disease in European UnionPARMA, Italy and CARMIEL, Israel , Dec. 9, 2024 /PRNewswire/ -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, and Protalix BioTherapeutics, Inc. (NYSE American:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today announced that the European Medicines Agency (EMA) has validated the Variation Submission for pegunigalsidase alfa ? to label a less frequent dosing regimen at a dose of 2 mg/kg body weight administered every four weeks in adult patients with Fabry disease. The currently approved dose of pegunigalsidase alfa is 1 mg/kg administered Show less Read more
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