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 ...

Core Opinion - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion regarding the revised dosing schedule for Elfabrio, a treatment for Fabry disease, proposed by Protalix BioTherapeutics and Chiesi Group [1][2]. Company Overview - Protalix BioTherapeutics and Chiesi Group are facing selling pressure following the CHMP's decision [2][5]. - The companies had requested approval for a new dosing regimen of 2 mg/kg body weight infused every 4 weeks, in addition to the currently approved regimen of 1 mg/kg body weight infused every 2 weeks [2]. Clinical Data - The CHMP review was based on data from the BRIGHT trial and an ongoing open-label extension study, which collectively provided a median exposure of almost six years [3][4]. - The data from these studies, along with modeling and exposure-response analyses from prior trials, were deemed insufficient to demonstrate similar efficacy for the new dosing schedule [4]. Market Impact - Following the negative opinion, Protalix BioTherapeutics' stock price decreased by 29.83%, closing at $1.68 [5].