---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-109639"
form_type: "8-K"
ticker: "QNRX"
cik: "0001671502"
company_name: "Quoin Pharmaceuticals, Ltd."
filed_at: "2026-09-22T20:15:34+00:00"
generated_at: "2026-09-22T20:18:21.676449+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA grants Fast Track to Quoin's QRX003 for Peeling Skin Syndrome

## Summary
- FDA granted Fast Track Designation to QRX003 for Peeling Skin Syndrome (PSS) on Sept 22, 2026.
- First-ever Fast Track for a PSS therapy; second Fast Track for QRX003 (prior: Netherton Syndrome).
- Follows July 2026 FDA clearance of first-ever IND for PSS; Phase 2/3 study planned 2H 2026.
- Phase 2/3 to enroll up to 12 pediatric/adult patients; targeting 2028 approval; no approved PSS treatment.

## SEC filing metadata
- accession: 0001104659-26-109639
- form_type: 8-K
- ticker: QNRX
- cik: 0001671502
- company_name: Quoin Pharmaceuticals, Ltd.
- filed_at: 2026-09-22T20:15:34+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/1671502/000110465926109639/0001104659-26-109639-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1671502/000110465926109639/tm2625948d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-109639
- JSON: https://secwatch.observer/filing/0001104659-26-109639.json
- Plain text: https://secwatch.observer/filing/0001104659-26-109639.txt

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