Protalix BioTherapeutics and partner secure EU approval for new Fabry disease dosing regimen [Yahoo! Finance]
Protalix BioTherapeutics, Inc. (DE) (PLX)
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Source: Yahoo! Finance
Protalix Biotherapeutics Inc (NYSE-A:PLX, FRA:PBDA) announced that the European Commission has approved a new dosing regimen for pegunigalsidase alfa for adults with Fabry disease who are stable on enzyme replacement therapy (ERT), triggering a $25 million regulatory milestone payment from partner Chiesi Global Rare Diseases. The approval allows eligible patients to receive the therapy at a dose of 2 mg/kg every four weeks, instead of the previous every-two-weeks schedule. According to the companies, the change could reduce the treatment burden for patients, their families and healthcare systems by extending the interval between infusions. The decision follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), which recommended the additional dosing regimen. The approval was supported by results from the open-label BRIGHT study, which evaluated the safety, efficacy and pharmacokinetics of the every-four-weeks regimen o
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News
- Protalix BioTherapeutics to Announce Fiscal Year 2025 Financial Results and Business Update on March 18, 2026PR Newswire
- Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce European Commission Approval of Additional Dosing Regimen of Every Four Weeks for Elfabrio® (pegunigalsidase alfa) [Yahoo! Finance]Yahoo! Finance
- Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce European Commission Approval of Additional Dosing Regimen of Every Four Weeks for Elfabrio® (pegunigalsidase alfa)GlobeNewswire
- Chiesi Global Rare Diseases and Protalix BioTherapeutics Receive Positive CHMP Opinion for an Additional Dosing Regimen of Every Four Weeks for Elfabrio® (pegunigalsidase alfa) in the EUGlobeNewswire
- Protalix BioTherapeutics Letter to StockholdersPR Newswire
PLX
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- 11/13/25 - Miss
PLX
Sec Filings
- 3/9/26 - Form 8-K
- 3/4/26 - Form SCHEDULE
- 2/11/26 - Form 8-K
- PLX's page on the SEC website