Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) announced on October 14, 2026, that its lead product candidate, QRX003, has been granted Orphan Drug Designation by the European Medicines Agency (EMA) for the treatment of Peeling Skin Syndrome.
The designation provides the company with several incentives, including scientific advice on study protocols, fee reductions, and access to EU grants. If QRX003 receives marketing authorization from the EMA, the company will be granted 10 years of market exclusivity in Europe for the treatment of this condition.
According to the filing, Quoin intends to initiate the first-ever formal clinical study for Peeling Skin Syndrome before the end of the year.
The company noted that QRX003 has now received eight important regulatory milestones across both Netherton Syndrome and Peeling Skin Syndrome, including four Orphan Drug designations by three major regulatory agencies and Fast Track Status from the U.S. Food and Drug Administration.
