Quoin Pharmaceuticals Announces European Medicines Agency (EMA) Grants Orphan Drug Designation for QRX003 for the Treatment of Peeling Skin Syndrome
Globe Newswire•14/10/2026•06:30 ET
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Key Highlights
- ➤EMA grants QRX003 Orphan Drug Designation for Peeling Skin Syndrome
- ➤QRX003 could receive 10 years’ European market exclusivity upon marketing authorization
- ➤Quoin on track to initiate Peeling Skin Syndrome trial before year end
- ➤QRX003 has reached eight regulatory milestones across two indications
Expert Statements
Dr. Michael Myers, CEO of Quoin Pharmaceuticals Ltd.
“We continue to make important clinical and regulatory progress for QRX003, both as a potential treatment for Netherton Syndrome and Peeling Skin Syndrome, and this milestone marks yet another significant step forward for Quoin. Cumulatively across both indications, QRX003 has now been granted four Orphan Drug designations by three major regulatory agencies, two Pediatric Rare Disease Designations from the US FDA as well as Fast Track Status for both indications in the US. These eight important regulatory milestones reflect both the innovative nature of the product and the recognition of the unmet medical needs it is targeting. We are on track to initiate the first-ever formal clinical study for Peeling Skin Syndrome, a severe rare skin disease that has long been underserved.”
– Company on track to initiate first-ever formal clinical trial in Peeling Skin Syndrome before year end
– Orphan Drug designation milestone provides 10 years of market exclusivity for Peeling Skin Syndrome in Europe after receipt of marketing authorization in the European Union
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