---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-101269"
form_type: "8-K"
ticker: "QNRX"
cik: "0001671502"
company_name: "Quoin Pharmaceuticals, Ltd."
filed_at: "2025-10-21T23:59:59+00:00"
generated_at: "2026-05-17T03:02:38.054644+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Quoin Pharmaceuticals receives FDA Orphan Drug Designation for QRX003 in Netherton Syndrome

## Summary
- FDA grants Orphan Drug Designation to QRX003 for Netherton Syndrome; 7-year US exclusivity if approved.
- Designation follows EMA Orphan Drug Designation granted in May 2025.
- Two pivotal trials ongoing; enrollment completion expected Q1 2026, top-line data H2 2026, NDA submission later 2026.
- QRX003 on track to become first approved treatment for Netherton Syndrome.

## SEC filing metadata
- accession: 0001104659-25-101269
- form_type: 8-K
- ticker: QNRX
- cik: 0001671502
- company_name: Quoin Pharmaceuticals, Ltd.
- filed_at: 2025-10-21T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1671502/000110465925101269/0001104659-25-101269-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1671502/000110465925101269/tm2529207d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-101269
- JSON: https://secwatch.observer/filing/0001104659-25-101269.json
- Plain text: https://secwatch.observer/filing/0001104659-25-101269.txt

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