regulatory
confidence high
sentiment positive
materiality 0.55
Quoin's QRX003 wins EMA Orphan Drug Designation for Peeling Skin Syndrome
Quoin Pharmaceuticals, Ltd.
- EMA granted Orphan Drug Designation to lead candidate QRX003 for Peeling Skin Syndrome on Oct 14, 2026, giving 10 years of EU market exclusivity if approved.
- Quoin says it is on track to initiate the first-ever formal clinical study in Peeling Skin Syndrome before year end.
- Designation is the eighth regulatory milestone for QRX003, which also holds US FDA Pediatric Rare Disease and Fast Track designations for the indication.
- QRX003 also has Orphan Drug Designation in the US, Europe and Japan for Netherton Syndrome, where it is in late-stage trials and no therapies are approved.
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