Chiesi Global Rare Diseases and Protalix BioTherapeutics Seek Re-examination from the EMA for the Negative Opinion for Elfabrio (pegunigalsidase alfa) Alternative Dosing Regimen of Every Four Weeks in the EU

PARMA, Italy and CARMIEL, Israel, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group, and Protalix BioTherapeutics, Inc. (NYSE American: PLX), have requested a re-examination of the recent negative opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding the proposed dosing regimen of 2 mg/kg body weight infused every 4 weeks (E4W) for Elfabrio® (pegunigalsidase alfa). The opinion concerns the ...