---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-115709"
form_type: "8-K"
ticker: "QNRX"
cik: "0001671502"
company_name: "Quoin Pharmaceuticals, Ltd."
filed_at: "2026-10-14T10:35:34+00:00"
generated_at: "2026-10-14T10:40:03.084397+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Quoin's QRX003 wins EMA Orphan Drug Designation for Peeling Skin Syndrome

## Summary
- EMA granted Orphan Drug Designation to lead candidate QRX003 for Peeling Skin Syndrome on Oct 14, 2026, giving 10 years of EU market exclusivity if approved.
- Quoin says it is on track to initiate the first-ever formal clinical study in Peeling Skin Syndrome before year end.
- Designation is the eighth regulatory milestone for QRX003, which also holds US FDA Pediatric Rare Disease and Fast Track designations for the indication.
- QRX003 also has Orphan Drug Designation in the US, Europe and Japan for Netherton Syndrome, where it is in late-stage trials and no therapies are approved.

## SEC filing metadata
- accession: 0001104659-26-115709
- form_type: 8-K
- ticker: QNRX
- cik: 0001671502
- company_name: Quoin Pharmaceuticals, Ltd.
- filed_at: 2026-10-14T10:35:34+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1671502/000110465926115709/0001104659-26-115709-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1671502/000110465926115709/tm2627548d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-115709
- JSON: https://secwatch.observer/filing/0001104659-26-115709.json
- Plain text: https://secwatch.observer/filing/0001104659-26-115709.txt

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