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Quoin Pharmaceuticals Announces European Medicines Agency (EMA) Grants Orphan Drug Designation for QRX003 for the Treatment of Peeling Skin Syndrome

QNRX
  • Quoin Pharmaceuticals received Orphan Drug Designation in Europe from the EMA for QRX003 to treat Peeling Skin Syndrome.
  • The designation grants QRX003 ten years of market exclusivity in Europe upon marketing authorization.
  • The Company plans to initiate the first-ever formal clinical trial for Peeling Skin Syndrome before the end of 2026.
  • QRX003 has now achieved eight regulatory milestones across both Peeling Skin Syndrome & Netherton Syndrome indications.
  • The product holds Pediatric Rare Disease & Fast Track Designations from the US FDA for Peeling Skin Syndrome.
  • QRX003 has received Orphan Drug Designation in the US, Europe, & Japan for Netherton Syndrome, along with US Pediatric Rare Disease & Fast Track Designations.
  • QRX003 is currently undergoing late-stage clinical trials for Netherton Syndrome, a severe rare disease with no approved therapies.
  • Quoin Pharmaceuticals is a late clinical-stage specialty company developing four products for rare & orphan diseases.