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.

3The new regimen is for adults with Fabry disease who are stable on enzyme replacement therapy (ERT).

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.