---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-052062"
form_type: "8-K"
ticker: "QNRX"
cik: "0001671502"
company_name: "Quoin Pharmaceuticals, Ltd."
filed_at: "2025-05-23T23:59:59+00:00"
generated_at: "2026-05-20T14:32:22.461471+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Quoin Pharma gets FDA clearance to start second pivotal Netherton Syndrome study for QRX003

## Summary
- FDA cleared Study CL-QRX003-002, testing whole-body QRX003 (~80% BSA) with off-label systemic therapy in ~12-15 subjects.
- Complements monotherapy pivotal study CL-QRX003-003 led by Dr. Amy Paller at Northwestern with up to 6 international sites.
- Five U.S. sites open; sixth expected in June; all sites have subject cohorts ready for rapid enrollment.
- Targets full recruitment into both pivotal studies by Q1 2026 and NDA filing later in 2026.
- Quoin claims only company running two late-stage whole-body pivotal NS studies.

## SEC filing metadata
- accession: 0001104659-25-052062
- form_type: 8-K
- ticker: QNRX
- cik: 0001671502
- company_name: Quoin Pharmaceuticals, Ltd.
- filed_at: 2025-05-23T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1671502/000110465925052062/0001104659-25-052062-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1671502/000110465925052062/tm2516001d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-052062
- JSON: https://secwatch.observer/filing/0001104659-25-052062.json
- Plain text: https://secwatch.observer/filing/0001104659-25-052062.txt

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