Protalix BioTherapeutics, Inc.
pegunigalsidase alfa
Fabry disease
Resolved
120days ago
Approval decision · Mar 9, 2026
What's at stake
A final FDA approval decision on pegunigalsidase alfa for Fabry disease is expected Mar 9, 2026.
Primary source
· SEC 8-K
verified 15h ago
“The European Commission (EC) has approved the 2mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio (pegunigalsidase alfa) in adults living with Fabry disease who are stable with an ERT.”