---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-23-000003"
form_type: "8-K"
ticker: "PLX"
cik: "0001006281"
company_name: "Protalix BioTherapeutics, Inc."
filed_at: "2023-01-03T23:59:59+00:00"
generated_at: "2026-06-20T20:40:17.721915+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Protalix updates on PRX-102 FDA PDUFA date May 9, 2023; PRX-115 Phase I in Q1 2023

## Summary
- MAA submitted to EMA Feb 2022; BLA resubmitted to FDA Nov 2022 with PDUFA goal date May 9, 2023.
- BALANCE study: PRX-102 statistically non-inferior to agalsidase beta on eGFR slope; BRIGHT: stable disease.
- PRX-115 (PEGylated uricase) for severe gout: Phase I trial planned for Q1 2023; preclinical data show stable PK and low immunogenicity.
- If PRX-102 approved by FDA, Protalix eligible for milestone payment from partner Chiesi.

## SEC filing metadata
- accession: 0001558370-23-000003
- form_type: 8-K
- ticker: PLX
- cik: 0001006281
- company_name: Protalix BioTherapeutics, Inc.
- filed_at: 2023-01-03T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1006281/000155837023000003/0001558370-23-000003-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1006281/000155837023000003/plx-20230103x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-23-000003
- JSON: https://secwatch.observer/filing/0001558370-23-000003.json
- Plain text: https://secwatch.observer/filing/0001558370-23-000003.txt

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