---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-23-020006"
form_type: "8-K"
ticker: "PLX"
cik: "0001006281"
company_name: "Protalix BioTherapeutics, Inc."
filed_at: "2023-12-26T23:59:59+00:00"
generated_at: "2026-06-07T07:11:53.716539+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Protalix updates on Elfabrio approvals, PRX-115 Phase I progress, and pipeline

## Summary
- Elfabrio (Fabry disease) approved by FDA and EMA; launched in US, EU, UK via Chiesi partnership.
- Phase I trial of PRX-115 (gout) completed 7th cohort with 56 patients dosed; completion expected Q2 2024.
- Preclinical development advancing for PRX-119 (DNase I for NETs-related diseases).
- CEO acknowledges ongoing challenges in Israel, reaffirms commitment to operations and pipeline.

## SEC filing metadata
- accession: 0001558370-23-020006
- form_type: 8-K
- ticker: PLX
- cik: 0001006281
- company_name: Protalix BioTherapeutics, Inc.
- filed_at: 2023-12-26T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1006281/000155837023020006/0001558370-23-020006-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1006281/000155837023020006/plx-20231226x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-23-020006
- JSON: https://secwatch.observer/filing/0001558370-23-020006.json
- Plain text: https://secwatch.observer/filing/0001558370-23-020006.txt

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