Chiesi Global Rare Diseases and Protalix Biotherapeutics Acknowledge CHMP Negative Opinion on Every Four Week Dosing Regimen of Elfabrio® (pegunigalsidase alfa) in the EU
Protalix BioTherapeutics, Inc. (DE) (PLX)
NASDAQ:AMEX Investor Relations:
phx.corporate-ir.net/phoenix.zhtml?c=101161&p=irol-irhome
Company Research
Source: GlobeNewswire
PARMA, Italy and CARMIEL, Israel, Oct. 17, 2025 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, and Protalix BioTherapeutics, Inc. (NYSE American:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, acknowledge that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion on the request to approve the dosing regimen of 2 mg/kg body weight infused every 4 weeks (E4W) for Elfabrio (pegunigalsidase alfa, in addition to the currently approved dosing regimen of 1 mg/kg body weight infused every 2 weeks (E2W). “We are disappointed by the result of this review but want to express our immense appreciation for the collaboration of
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PLX
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- 11/13/25 - Miss
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- 11/19/25 - Form 4
- 11/13/25 - Form 10-Q
- 11/13/25 - Form 8-K
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