---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-051324"
form_type: "8-K"
ticker: "QNRX"
cik: "0001671502"
company_name: "Quoin Pharmaceuticals, Ltd."
filed_at: "2025-05-21T23:59:59+00:00"
generated_at: "2026-05-20T22:36:12.650156+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Quoin Pharma gets EMA Orphan Drug Designation for QRX003 for Netherton Syndrome

## Summary
- EMA grants Orphan Drug Designation for QRX003, a topical treatment for Netherton Syndrome, a rare disease with no approved therapies.
- ODD provides 10 years of market exclusivity in Europe upon approval, plus fee reductions and access to EU grants.
- QRX003 is in multiple late-stage clinical trials; CEO cites skin healing and pruritus elimination in pediatric study.

## SEC filing metadata
- accession: 0001104659-25-051324
- form_type: 8-K
- ticker: QNRX
- cik: 0001671502
- company_name: Quoin Pharmaceuticals, Ltd.
- filed_at: 2025-05-21T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1671502/000110465925051324/0001104659-25-051324-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1671502/000110465925051324/tm2515741d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-051324
- JSON: https://secwatch.observer/filing/0001104659-25-051324.json
- Plain text: https://secwatch.observer/filing/0001104659-25-051324.txt

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