{"url_path":"/sec/plx/8-k/2026-01-30/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 ****Other Events**","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-01-30","source_url":"https://www.sec.gov/Archives/edgar/data/1006281/0001104659-26-008410-index.html","accession_number":"0001104659-26-008410","cik":"0001006281","ticker":"PLX","issuer_name":"Protalix BioTherapeutics, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1006281/0001104659-26-008410-index.html","primary_entity_key":"0001006281","primary_entity_name":"Protalix BioTherapeutics, Inc."},"word_count":107,"has_tables":true,"body_markdown":"**Item 8.01****Other Events**\n\n \n\nOn\nJanuary 30, 2026, Protalix BioTherapeutics, Inc., a Delaware corporation (the “Company”), issued a press release,\ntogether with its development and commercialization partner, Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici S.p.A.,\nannouncing that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a\npositive opinion recommending approval of the 2 mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio® in Fabry\ndisease adult patients stable with an ERT (Enzyme Replacement Therapy) treatment. A\ncopy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by\nreference."}