Quoin Pharmaceuticals announces FDA granted ODD to QRX003

Quoin Pharmaceuticals (QNRX) announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation, ODD, to its lead product candidate, QRX003, for the treatment of Netherton Syndrome. The designation follows previously granted Orphan Drug Designation by the European Medicines Agency in May 2025. “Receiving Orphan Drug Designation from the FDA is yet another important milestone in our mission to bring QRX003 to patients suffering with Netherton Syndrome,” said Dr. Michael Myers, CEO of Quoin Pharmaceuticals. “Together with the EMA designation granted earlier in the year, this latest recognition by the FDA could potentially help facilitate the pathway of QRX003 to approval in the US whilst providing significant data protection to the product, if approved. Quoin remains steadfastly committed to completing the clinical development of QRX003 with a high degree of urgency on behalf of patients and families living with this devastating disease.”