UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events |
On January 30, 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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of the 2 mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio® in Fabry disease adult patients stable with an ERT (Enzyme Replacement Therapy) treatment. 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.
| Item 9.01 | Financial Statements and Exhibits |
|
Exhibit No. |
Description | |
| 99.1 | Press Release dated January 30, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: January 30, 2026 |
PROTALIX BIOTHERAPEUTICS, INC. | ||
| By: | /s/ Dror Bashan | ||
| Name: | Dror Bashan | ||
| Title: | President and Chief Executive Officer | ||