---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-005127"
form_type: "8-K"
ticker: "QNRX"
cik: "0001671502"
company_name: "Quoin Pharmaceuticals, Ltd."
filed_at: "2026-01-20T23:59:59+00:00"
generated_at: "2026-05-16T09:33:44.351680+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Quoin seeks SFDA breakthrough designation; QRX003 could be first approved Netherton treatment in 2H2026

## Summary
- Filed application with Saudi FDA for Breakthrough Medicine Designation for QRX003 for Netherton Syndrome.
- If granted, QRX003 could be approved for sale/reimbursement in Saudi Arabia by 2H 2026, first-ever approved treatment for Netherton Syndrome.
- Two pivotal trials for QRX003 lotion (4%) enrollment expected to complete 1H 2026; top-line data in 2H 2026.
- NDA submission planned in US and other territories in late 2026/early 2027, subject to clinical outcomes.
- As of Jan 20, 2026, Quoin has 1,616,179 ADSs outstanding.

## SEC filing metadata
- accession: 0001104659-26-005127
- form_type: 8-K
- ticker: QNRX
- cik: 0001671502
- company_name: Quoin Pharmaceuticals, Ltd.
- filed_at: 2026-01-20T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1671502/000110465926005127/0001104659-26-005127-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1671502/000110465926005127/tm263667d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-005127
- JSON: https://secwatch.observer/filing/0001104659-26-005127.json
- Plain text: https://secwatch.observer/filing/0001104659-26-005127.txt

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