Protalix BioTherapeutics, Inc.
pegunigalsidase alfa
Fabry disease
Date
TBD
FDA decision · Date TBD estimated
What's at stake
The FDA's approval decision on pegunigalsidase alfa for Fabry disease is due Date TBD. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 8-K
verified 14h ago
“the EC will not approve the CHMP’s positive opinion recommending approval of the 2mg/kg every-4-weeks (E4W) dosing regimen for pegunigalsidase alfa in adults with Fabry disease”