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PLX Protalix BioTherapeutics

Protalix BioTherapeutics Inc is a commercial-stage biopharmaceutical company focused on the discovery, development, production, and commercialization of therapeutics for rare diseases with important unmet needs. ProCellEx, a proprietary plant cell-based protein expression system, represents a new method for developing …

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May 21, 2026

11:03 AM

PLXProtalix BioTherapeutics

Protalix: EC/MHRA approve Elfabrio E4W dosing for Fabry

European Commission and MHRA approved a novel 2 mg/kg every-4-weeks dosing regimen for Elfabrio in adults with Fabry disease who are stable on ERT, making it the only ERT in the EU/UK offering an E4W option. Protalix received a $25 million regulatory milestone payment from Chiesi. FDA-approved dosing in the US remains 1 mg/kg every 2 weeks.

FDA label updateSEC 8-K Open record