---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-024975"
form_type: "8-K"
ticker: "PLX"
cik: "0001006281"
company_name: "Protalix BioTherapeutics, Inc."
filed_at: "2026-03-09T23:59:59+00:00"
generated_at: "2026-05-15T17:26:24.899059+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# EC approves Elfabrio every-4-weeks dosing; Protalix gets $25M milestone

## Summary
- European Commission approved 2 mg/kg every-4-weeks regimen for Elfabrio in stable adult Fabry patients.
- Decision follows positive CHMP opinion; dosing reduces infusion frequency from every-2-weeks.
- Protalix entitled to a $25 million regulatory milestone payment from Chiesi upon EC approval.
- US FDA-approved dosing remains 1 mg/kg every 2 weeks; not affected by EU decision.
- BRIGHT study (PB-102-F50) and extension study supported the alternative dosing regimen.

## SEC filing metadata
- accession: 0001104659-26-024975
- form_type: 8-K
- ticker: PLX
- cik: 0001006281
- company_name: Protalix BioTherapeutics, Inc.
- filed_at: 2026-03-09T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1006281/000110465926024975/0001104659-26-024975-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1006281/000110465926024975/plx-20260309x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-024975
- JSON: https://secwatch.observer/filing/0001104659-26-024975.json
- Plain text: https://secwatch.observer/filing/0001104659-26-024975.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.