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FDA grants Fast Track Designation to QRX003 for Peeling Skin Syndrome, the first such status for this rare genetic disease
QNRXQuoin Pharmaceuticals Ltd.
On September 22, 2026, Quoin Pharmaceuticals Ltd. announced that the U.S. Food and Drug Administration granted Fast Track Designation to QRX003 for the treatment of Peeling Skin Syndrome. This is the first such designation for a therapy targeting this rare genetic skin disease, which currently has no approved treatments. It marks the second indication for which QRX003 received Fast Track status, following Netherton Syndrome designated in March 2026. The designation follows FDA clearance of Quoin's Investigational New Drug application in July 2026. The company expects to initiate a Phase 2/3 clinical study enrolling up to 12 patients in the second half of 2026, targeting potential approval by 2028. Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases.