---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-000393"
form_type: "8-K"
ticker: "PLX"
cik: "0001006281"
company_name: "Protalix BioTherapeutics, Inc."
filed_at: "2026-01-05T23:59:59+00:00"
generated_at: "2026-05-16T11:36:50.218361+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Protalix provides business update; PRX-115 Phase 2 IND effective, gout market focus

## Summary
- PRX-115 Phase 1 data show rapid, durable urate lowering lasting 12 weeks at higher doses; Phase 2 IND effective.
- Fabry drug Elfabrio launched through Chiesi; CHMP negative opinion on E4W dosing under appeal, outcome Q1 2026.
- Fabry market projected $3.4B by 2030; Elfabrio target capture 15-20% share.
- Elelyso revenue continues via Pfizer and Fiocruz partnerships.
- New renal pipeline includes PRX-119 (long-acting DNase I) and Secarna RNA collaboration.

## SEC filing metadata
- accession: 0001104659-26-000393
- form_type: 8-K
- ticker: PLX
- cik: 0001006281
- company_name: Protalix BioTherapeutics, Inc.
- filed_at: 2026-01-05T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1006281/000110465926000393/0001104659-26-000393-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1006281/000110465926000393/plx-20260105x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-000393
- JSON: https://secwatch.observer/filing/0001104659-26-000393.json
- Plain text: https://secwatch.observer/filing/0001104659-26-000393.txt

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