Protalix and Chiesi receive CHMP negative opinion on every-4-week dosing for Elfabrio in EU

Protalix BioTherapeutics, Inc.

CHMP issued negative opinion for 2 mg/kg every 4 weeks dosing of Elfabrio (pegunigalsidase alfa) for Fabry disease.
Currently approved dosing regimen of 1 mg/kg every 2 weeks remains unchanged in the EU.
Decision based on BRIGHT trial and modeling; data insufficient to conclude similar efficacy.
Chiesi and Protalix express disappointment but reaffirm commitment to Fabry community.
No financial guidance or other material impact disclosed in the filing.

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