---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-105594"
form_type: "8-K"
ticker: "PLX"
cik: "0001006281"
company_name: "Protalix BioTherapeutics, Inc."
filed_at: "2025-11-03T23:59:59+00:00"
generated_at: "2026-05-17T00:48:34.771967+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Protalix and Chiesi request re-examination of negative EMA opinion on Elfabrio E4W dosing regimen

## Summary
- CHMP issued negative opinion on Elfabrio 2 mg/kg every-4-weeks dosing regimen; re-examination requested.
- Existing EU marketing authorization for every-2-weeks regimen remains in effect pending outcome.
- Approved E2W dosing regimen unchanged; companies committed to addressing Fabry community needs.
- Re-examination process underway; timeline for final EC decision not disclosed.

## SEC filing metadata
- accession: 0001104659-25-105594
- form_type: 8-K
- ticker: PLX
- cik: 0001006281
- company_name: Protalix BioTherapeutics, Inc.
- filed_at: 2025-11-03T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1006281/000110465925105594/0001104659-25-105594-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1006281/000110465925105594/plx-20251103x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-105594
- JSON: https://secwatch.observer/filing/0001104659-25-105594.json
- Plain text: https://secwatch.observer/filing/0001104659-25-105594.txt

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