Protalix BioTherapeutics (PLX) 8-K Summary

• Regulatory Action: PLX and partner Chiesi requested a re-examination by the EMA’s CHMP concerning the negative opinion previously issued for the proposed dosing regimen of Elfabrio® (pegunigalsidase alfa) (2 mg/kg E4W).
• Significance: This filing signals an active challenge to the initial European regulatory setback for a key asset. Investors should monitor the outcome of this re-examination, as it directly impacts European commercialization prospects.
• Management: Report signed by CEO Dror Bashan.

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