Quoin Pharmaceuticals Announces U.S. FDA Grants Orphan Drug Designation for QRX003 in Netherton Syndrome

Core Points - Quoin Pharmaceuticals has received Orphan Drug Designation from the FDA for its product QRX003, aimed at treating Netherton Syndrome, following a similar designation from the EMA in May 2025 [1][2][3] - The FDA's Orphan Drug Designation provides benefits such as tax credits for clinical testing, waiver of FDA application fees, and seven years of market exclusivity upon approval [2] - QRX003 is currently undergoing two late-stage pivotal clinical trials, with enrollment expected to complete in Q1 2026 and top-line data anticipated in the second half of 2026 [3] Company Overview - Quoin Pharmaceuticals is a late clinical-stage specialty pharmaceutical company focused on developing treatments for rare and orphan diseases [4] - The company's pipeline includes products targeting various rare conditions, including Netherton Syndrome, Peeling Skin Syndrome, and others [4]