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 F...
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, 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 request to add the E4W dosing regimen to the currently approved 1 mg/kg every 2 weeks (E2W) regimen. The existing marketing authorization for Elfabrio remains in effect pending the outcome of the re-examination procedure and subsequent decision by the European Commission (EC). Both Chiesi and Protalix remain fully committed to working closely with the EMA through the re-examination process and to addressing the high unmet medical needs of the Fabry community. Important Safety
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Earnings
- 11/13/25 - Miss
PLX
Sec Filings
- 11/19/25 - Form 4
- 11/13/25 - Form 10-Q
- 11/13/25 - Form 8-K
- PLX's page on the SEC website