---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-008410"
form_type: "8-K"
ticker: "PLX"
cik: "0001006281"
company_name: "Protalix BioTherapeutics, Inc."
filed_at: "2026-01-30T23:59:59+00:00"
generated_at: "2026-05-16T05:52:33.705698+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Protalix gets positive CHMP opinion for every-4-week dosing of Elfabrio in EU; $25M milestone if EC approves

## Summary
- CHMP issued positive opinion for 2 mg/kg every-4-weeks dosing regimen of Elfabrio for stable Fabry adults.
- Positive opinion follows re-examination; EC decision expected by March 2026.
- Protalix eligible for $25M regulatory milestone from Chiesi if EC approves the regimen.
- The extended dosing interval aims to reduce treatment burden; regimen not approved in U.S.
- BRIGHT study and ongoing extension with median exposure ~6 years supported the opinion.

## SEC filing metadata
- accession: 0001104659-26-008410
- form_type: 8-K
- ticker: PLX
- cik: 0001006281
- company_name: Protalix BioTherapeutics, Inc.
- filed_at: 2026-01-30T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1006281/000110465926008410/0001104659-26-008410-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1006281/000110465926008410/tm264565d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-008410
- JSON: https://secwatch.observer/filing/0001104659-26-008410.json
- Plain text: https://secwatch.observer/filing/0001104659-26-008410.txt

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