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StocksMedium•9 March 2026•

1 min read

Protalix Secures EU Approval for New Fabry Disease Dosing and $25M Milestone Payment

Key Facts

1The European Commission approved a new dosing regimen for pegunigalsidase alfa at 2 mg/kg every four weeks.

2The approval triggered a $25 million regulatory milestone payment from partner Chiesi Global Rare Diseases to Protalix.

Protalix BioTherapeutics and its partner Chiesi Global Rare Diseases announced that the European Commission has approved a new dosing regimen for pegunigalsidase alfa. The approval allows for a dosage of 2 mg/kg every four weeks for adult patients with Fabry disease who have stabilized on enzyme replacement therapy (ERT). This regulatory milestone has triggered a significant $25 million payment from Chiesi to Protalix, strengthening the company's financial position and balance sheet. The new schedule offers a more flexible treatment option compared to the standard bi-weekly dosing, potentially improving patient convenience and adherence. Analysts view this development as a positive catalyst for Protalix, as it expands the market reach of its therapy while providing immediate non-dilutive capital. The company continues to focus on enhancing treatment options for rare genetic disorders through its proprietary ProCellEx platform.