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FDA grants Rare Pediatric Disease Designation to QRX003 for Peeling Skin Syndrome, second such honor for the asset
QNRXQuoin Pharmaceuticals Ltd.
On September 8, 2026, Quoin Pharmaceuticals Ltd. announced that the U.S. Food and Drug Administration granted Rare Pediatric Disease Designation for its lead asset, QRX003, to treat Peeling Skin Syndrome. This marks the second such designation for QRX003, following a prior grant for Netherton Syndrome. The company stated it expects to initiate a Phase 2 clinical study before the end of 2026, planning to enroll up to 12 pediatric and adult patients in the U.S. and Europe under an open Investigational New Drug application. Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products for rare and orphan diseases.