{"url_path":"/sec/plx/8-k/2026-03-09/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 **","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-03-09","source_url":"https://www.sec.gov/Archives/edgar/data/1006281/0001104659-26-024975-index.html","accession_number":"0001104659-26-024975","cik":"0001006281","ticker":"PLX","issuer_name":"Protalix BioTherapeutics, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1006281/0001104659-26-024975-index.html","primary_entity_key":"0001006281","primary_entity_name":"Protalix BioTherapeutics, Inc."},"word_count":125,"has_tables":true,"body_markdown":"**Item 8.01**\n\n**Other Events**\n\n​\n\nOn March 9, 2026, Protalix BioTherapeutics, Inc., a Delaware corporation (the “Company”), issued a press release, together with its development and commercialization partner, Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici S.p.A., announcing that the European Commission (EC) has approved the 2 mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio® (pegunigalsidase alfa) in adults living with Fabry disease who are stable with an ERT (Enzyme Replacement Therapy). The EC decision follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the additional dosing regimen. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.\n\n​"}