Protalix gets positive CHMP opinion for every-4-week dosing of Elfabrio in EU; $25M milestone if EC approves

Protalix BioTherapeutics, Inc.

CHMP issued positive opinion for 2 mg/kg every-4-weeks dosing regimen of Elfabrio for stable Fabry adults.
Positive opinion follows re-examination; EC decision expected by March 2026.
Protalix eligible for $25M regulatory milestone from Chiesi if EC approves the regimen.
The extended dosing interval aims to reduce treatment burden; regimen not approved in U.S.
BRIGHT study and ongoing extension with median exposure ~6 years supported the opinion.

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