---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-23-010565"
form_type: "8-K"
ticker: "PLX"
cik: "0001006281"
company_name: "Protalix BioTherapeutics, Inc."
filed_at: "2023-05-30T23:59:59+00:00"
generated_at: "2026-06-14T11:04:13.923818+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Protalix announces FDA and EU approval of Elfabrio for Fabry disease; investor event June 27

## Summary
- Elfabrio (pegunigalsidase alfa) approved in both US and EU for adult Fabry disease patients.
- Commercial partner Chiesi Global Rare Diseases is prepared for launch.
- In-person investor event scheduled for June 27, 2023 at Lotte Palace Hotel, New York City.
- CEO Dror Bashan highlights ProCellEx platform and pipeline programs for future growth.

## SEC filing metadata
- accession: 0001558370-23-010565
- form_type: 8-K
- ticker: PLX
- cik: 0001006281
- company_name: Protalix BioTherapeutics, Inc.
- filed_at: 2023-05-30T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1006281/000155837023010565/0001558370-23-010565-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1006281/000155837023010565/plx-20230530x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-23-010565
- JSON: https://secwatch.observer/filing/0001558370-23-010565.json
- Plain text: https://secwatch.observer/filing/0001558370-23-010565.txt

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