Protalix BioTherapeutics, Inc.
Elfabrio
Fabry disease
Date
TBD
Advisory committee · Date TBD estimated
What's at stake
An FDA advisory committee reviews Elfabrio for Fabry disease around Date TBD. The panel's public vote often front-runs the agency's final verdict — and the share price.
Primary source
· SEC 8-K
verified 15h ago
“The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of the 2mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio in Fabry disease adult patien”