Quoin Pharmaceuticals (NASDAQ: QNRX) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead product candidate, QRX003, for the treatment of Netherton Syndrome, a rare and life-threatening genetic skin disease. The designation follows a similar recognition by the European Medicines Agency (EMA) in May 2025.
Under the FDA’s ODD program, Quoin will receive seven years of marketing exclusivity in the U.S. upon approval of QRX003, along with incentives such as tax credits for qualified clinical testing and waiver or partial payment of FDA application fees. QRX003 is on track to potentially become the first approved treatment for Netherton Syndrome, addressing a major unmet need for patients living with this debilitating condition.
“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 U.S. 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.”
Quoin is currently finalizing preparations to evaluate QRX003 lotion in 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.
Earlier this month, Quoin strengthened its balance sheet through a private placement financing of up to $104.5 million with participation from leading healthcare-focused institutional investors. The financing is expected to fully finance the company through completion of the pivotal trials.
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