---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-23-008188"
form_type: "8-K"
ticker: "PLX"
cik: "0001006281"
company_name: "Protalix BioTherapeutics, Inc."
filed_at: "2023-05-05T23:59:59+00:00"
generated_at: "2026-06-15T15:34:51.021047+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# European Commission approves Protalix's PRX-102 for Fabry disease in EU

## Summary
- EC granted marketing authorization to PRX-102 (pegunigalsidase alfa) for adult Fabry disease patients.
- Approval based on clinical program in >140 patients with up to 7.5 years of treatment.
- PRX-102 showed non-inferior efficacy to agalsidase beta in controlling kidney disease (eGFR decline).
- PRX-102 is not yet approved by FDA; U.S. review ongoing.
- Partner Chiesi Global Rare Diseases will commercialize in the EU.

## SEC filing metadata
- accession: 0001558370-23-008188
- form_type: 8-K
- ticker: PLX
- cik: 0001006281
- company_name: Protalix BioTherapeutics, Inc.
- filed_at: 2023-05-05T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1006281/000155837023008188/0001558370-23-008188-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1006281/000155837023008188/plx-20230505x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-23-008188
- JSON: https://secwatch.observer/filing/0001558370-23-008188.json
- Plain text: https://secwatch.observer/filing/0001558370-23-008188.txt

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