---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-076822"
form_type: "8-K"
ticker: "QNRX"
cik: "0001671502"
company_name: "Quoin Pharmaceuticals, Ltd."
filed_at: "2026-06-23T20:15:28+00:00"
generated_at: "2026-06-23T20:17:44.877947+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Quoin Pharma gets FDA conditional approval of brand name QYLEKI for Netherton Syndrome candidate

## Summary
- FDA conditionally approved QYLEKI as proposed brand name for QRX003, an investigational treatment for Netherton Syndrome.
- No approved treatment currently exists; QRX003 could become the first if approved.
- Pivotal Phase 3 study expected to initiate in H2 2026; potential NDA filing in 2027.
- QRX003 holds Orphan Drug Designations in US, EU, Japan; Fast Track and Rare Pediatric Disease Designations from FDA.
- Positive clinical update from ongoing Pediatric Compassionate Use Program released June 16, 2026.

## SEC filing metadata
- accession: 0001104659-26-076822
- form_type: 8-K
- ticker: QNRX
- cik: 0001671502
- company_name: Quoin Pharmaceuticals, Ltd.
- filed_at: 2026-06-23T20:15:28+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/1671502/000110465926076822/0001104659-26-076822-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1671502/000110465926076822/tm2618505d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-076822
- JSON: https://secwatch.observer/filing/0001104659-26-076822.json
- Plain text: https://secwatch.observer/filing/0001104659-26-076822.txt

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