---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-106705"
form_type: "8-K"
ticker: "QNRX"
cik: "0001671502"
company_name: "Quoin Pharmaceuticals, Ltd."
filed_at: "2026-09-10T20:05:43+00:00"
generated_at: "2026-09-10T20:07:31.740767+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA grants Rare Pediatric Disease Designation for QRX003 in Peeling Skin Syndrome

## Summary
- Second RPD designation for QRX003; first was for Netherton Syndrome.
- If NDA approved, Quoin may receive a Priority Review Voucher (PRV), which can be sold or transferred.
- Phase 2 study expected to initiate in 2H 2026, enrolling up to 12 pediatric and adult PSS patients in U.S. and Europe.
- No approved treatments currently exist for Peeling Skin Syndrome.

## SEC filing metadata
- accession: 0001104659-26-106705
- form_type: 8-K
- ticker: QNRX
- cik: 0001671502
- company_name: Quoin Pharmaceuticals, Ltd.
- filed_at: 2026-09-10T20:05:43+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1671502/000110465926106705/0001104659-26-106705-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1671502/000110465926106705/tm2625203d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-106705
- JSON: https://secwatch.observer/filing/0001104659-26-106705.json
- Plain text: https://secwatch.observer/filing/0001104659-26-106705.txt

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