Filing Analysis
Regulation FD Disclosure
Filed Mar 18, 2026
LOW
Protalix BioTherapeutics announced its financial results for the fiscal year ended December 31, 2025, and provided a business and clinical update.
Key Facts
- The filing was made on March 18, 2026, to report results for the fiscal year ended December 31, 2025.
- The company furnished a press release as Exhibit 99.1 containing the financial data and clinical updates.
- The report was filed under Item 2.02 (Results of Operations and Financial Condition).
- The information in the report is furnished and not deemed 'filed' for purposes of Section 18 of the Exchange Act.
Other SEC Filing
Filed Mar 09, 2026
LOW
Protalix BioTherapeutics announced that the European Commission has approved a new 2 mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio® (pegunigalsidase alfa). This approval provides an additional dosing option for adults living with Fabry disease who are stable on Enzyme Replacement Therapy.
Key Facts
- On March 9, 2026, the European Commission (EC) approved a 2 mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio®.
- The approval is specifically for adults living with Fabry disease who are stable with an Enzyme Replacement Therapy (ERT).
- The EC decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
- Elfabrio® is being commercialized in partnership with Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici S.p.A.
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