Quoin receives EU orphan drug designation for QRX003

• Quoin Pharmaceuticals (NASDAQ:QNRX) received European Medicines Agency orphan drug designation for QRX003, an investigational treatment for Peeling Skin Syndrome.
• The designation provides regulatory support, including scientific advice, potential fee reductions, and access to European Union incentives.
• Quoin expects to begin a formal Peeling Skin Syndrome clinical trial before the end of 2026.

Quoin Pharmaceuticals (NASDAQ:QNRX) announced that the European Medicines Agency has granted orphan drug designation to QRX003 for the treatment of Peeling Skin Syndrome, a rare genetic skin disorder.

The designation provides benefits including regulatory support on clinical development plans, reduced fees, and potential access to EU funding programs.

If QRX003 receives European marketing approval, the designation could provide 10 years of market exclusivity against similar medicines for the condition.

Quoin said QRX003 already holds U.S. Pediatric Rare Disease and Fast Track designations for Peeling Skin Syndrome and is expected to enter a formal clinical trial before year-end 2026.

The company is also developing QRX003 for Netherton Syndrome, where the program has received orphan drug designations in the United States, Europe, and Japan, along with U.S. Pediatric Rare Disease and Fast Track designations.

The program is currently undergoing late-stage clinical trials.

Quoin Pharmaceuticals focuses on developing treatments for rare dermatological diseases with significant unmet medical needs.