EMA grants orphan drug status to Quoin's QRX003 for Peeling Skin Syndrome

Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) disclosed in an October 14, 2026 Form 8-K that the European Medicines Agency has granted Orphan Drug Designation to its lead candidate QRX003 for the treatment of Peeling Skin Syndrome.

The designation comes with certain benefits in Europe. The company said the designation provides incentive benefits including scientific advice on study protocols, fee reductions and access to EU grants.¹ If QRX003 later receives marketing approval from the EMA, the company said it would be granted 10 years of market exclusivity in Europe for similar medicines treating Peeling Skin Syndrome.¹

Quoin said it intends to start its first formal clinical study in Peeling Skin Syndrome before the end of the year.¹

CEO Michael Myers said the designation represents continued progress for QRX003 in both Netherton Syndrome and Peeling Skin Syndrome. He noted that, across the two indications, QRX003 has now received four orphan drug designations from three major regulatory agencies, two Pediatric Rare Disease Designations from the FDA, and Fast Track status for both indications in the US, which he said reflects the product's innovative nature and the unmet needs it targets.¹

QRX003 is also in late-stage clinical trials for Netherton Syndrome, a severe rare disease for which no approved therapies currently exist.¹

Quoin describes itself as a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases. Its pipeline includes four products in development aimed at a range of rare and orphan conditions, among them Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa, Microcystic Lymphatic Malformations, Venous Malformations and Angiofibroma.¹