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Quoin Pharmaceuticals’ Lead Product Candidate QRX003 Granted Orphan Drug Designation By European Medicines Agency For Treatment Of Peeling Skin Syndrome

Benzinga·10/14/2026 10:33:04

– 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

– Designation Represents Eighth Important Regulatory Milestone for QRX003

– QRX003 has also been granted Pediatric Rare Disease Designation and Fast Track Designation for Peeling Skin Syndrome from US Food and Drug Administration

– In Netherton Syndrome, QRX003 has been granted Orphan Drug Designation in US, Europe and Japan as well as Pediatric Rare Disease and Fast Track Designations in the US

ASHBURN, Va., Oct. 14, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ:QNRX) (the "Company" or "Quoin"), a late clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today announces that its lead product candidate QRX003 has been granted Orphan Drug Designation in Europe by the European Medicines Agency (EMA) for the treatment of Peeling Skin Syndrome.

Orphan Drug Designation in Europe affords the Company incentive benefits including scientific advice on study protocols, various fee reductions and access to EU grants. If approved for marketing by the EMA, QRX003 will be granted 10 years of market exclusivity in Europe with respect to similar medicines for the treatment of Peeling Skin Syndrome.