Israeli drugmaker Protalix BioTherapeutics (TASE: PLX) closed 40% up on Monday amid good news for pegunigalsidase alfa, the Fabry disease candidate that it is advancing alongside its development and commercialization partner, Chiesi Farmaceutici.
The companies have held a successful Type B Pre-Biologics License Application (BLA) meeting with the US Food and Drug Administration (FDA), during which they reached alignment with the FDA on the Accelerated Approval pathway for pegunigalsidase alfa.
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