regulatory
confidence high
sentiment positive
materiality 0.70
Quoin Pharmaceuticals receives FDA Orphan Drug Designation for QRX003 in Netherton Syndrome
Quoin Pharmaceuticals, Ltd.
- FDA grants Orphan Drug Designation to QRX003 for Netherton Syndrome; 7-year US exclusivity if approved.
- Designation follows EMA Orphan Drug Designation granted in May 2025.
- Two pivotal trials ongoing; enrollment completion expected Q1 2026, top-line data H2 2026, NDA submission later 2026.
- QRX003 on track to become first approved treatment for Netherton Syndrome.