---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-22-017549"
form_type: "8-K"
ticker: "PLX"
cik: "0001006281"
company_name: "Protalix BioTherapeutics, Inc."
filed_at: "2022-11-14T23:59:59+00:00"
generated_at: "2026-06-21T19:13:13.422855+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Protalix resubmits BLA for PRX-102 for Fabry disease; Q3 revenue up 96% YoY

## Summary
- BLA resubmitted to FDA on Nov 9, 2022; FDA review expected within six months; milestone payment due upon approval.
- Q3 2022 revenue from selling goods $8.8M up 96% YoY; net loss $3.6M ($0.07/share) vs loss $4.2M ($0.09).
- Cash and equivalents $20.8M as of Sep 30, 2022.
- BLA includes data from over 140 patients, phase III BALANCE, BRIDGE, BRIGHT studies, and phase I/II extension.
- Chiesi Global Rare Diseases is commercialization partner; EMA also reviewing MAA for PRX-102.

## SEC filing metadata
- accession: 0001558370-22-017549
- form_type: 8-K
- ticker: PLX
- cik: 0001006281
- company_name: Protalix BioTherapeutics, Inc.
- filed_at: 2022-11-14T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1006281/000155837022017549/0001558370-22-017549-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1006281/000155837022017549/plx-20221109x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-22-017549
- JSON: https://secwatch.observer/filing/0001558370-22-017549.json
- Plain text: https://secwatch.observer/filing/0001558370-22-017549.txt

## Key facts
- Earnings Releases
  Protalix BioTherapeutics, Inc. reported financial results for the third quarter ended September 30, 2022.
  - Period: the third quarter ended September 30, 2022
  - Result: reported results
  source text: On November 14, 2022, Protalix BioTherapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2022 and provided a business update on recent corporate and regulatory developments.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1006281/000155837022017549/0001558370-22-017549-index.htm

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