Protalix BioTherapeutics, Inc. 8-K

What Happened
Protalix BioTherapeutics, Inc. (PLX) and partner Chiesi Global Rare Diseases announced on January 30, 2026 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of Elfabrio® at a 2 mg/kg every-4-weeks (E4W) dosing regimen. The recommendation applies to adult patients with Fabry disease who are stable on an enzyme replacement therapy (ERT). The company filed an 8-K and attached the joint press release as Exhibit 99.1.

Key Details

• Filing date: January 30, 2026 (Form 8-K, Item 8.01) with press release attached as Exhibit 99.1.
• Regulator: CHMP (Committee for Medicinal Products for Human Use) of the European Medicines Agency (EMA).
• Recommendation: Approval of Elfabrio 2 mg/kg administered every 4 weeks (E4W) for adult Fabry patients stable on ERT.
• Partner: Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici S.p.A., co-issued the announcement.

Why It Matters
A positive CHMP opinion is a key regulatory milestone in the EU approval process and typically precedes a final European Commission decision. For investors, this moves Elfabrio closer to potential commercial availability in Europe for a defined patient group, which could affect Protalix’s future market opportunity and revenue potential if final approval and commercialization follow. The 8-K and attached press release are the company’s official public disclosures of the development; investors should watch for subsequent regulatory steps and commercialization updates.