---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-100264"
form_type: "8-K"
ticker: "PLX"
cik: "0001006281"
company_name: "Protalix BioTherapeutics, Inc."
filed_at: "2025-10-17T23:59:59+00:00"
generated_at: "2026-05-17T03:20:31.084519+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Protalix and Chiesi receive CHMP negative opinion on every-4-week dosing for Elfabrio in EU

## Summary
- CHMP issued negative opinion for 2 mg/kg every 4 weeks dosing of Elfabrio (pegunigalsidase alfa) for Fabry disease.
- Currently approved dosing regimen of 1 mg/kg every 2 weeks remains unchanged in the EU.
- Decision based on BRIGHT trial and modeling; data insufficient to conclude similar efficacy.
- Chiesi and Protalix express disappointment but reaffirm commitment to Fabry community.
- No financial guidance or other material impact disclosed in the filing.

## SEC filing metadata
- accession: 0001104659-25-100264
- form_type: 8-K
- ticker: PLX
- cik: 0001006281
- company_name: Protalix BioTherapeutics, Inc.
- filed_at: 2025-10-17T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1006281/000110465925100264/0001104659-25-100264-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1006281/000110465925100264/plx-20251017x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-100264
- JSON: https://secwatch.observer/filing/0001104659-25-100264.json
- Plain text: https://secwatch.observer/filing/0001104659-25-100264.txt

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