FDA grants second Rare Pediatric Disease designation to Quoin's QRX003

Quoin Pharmaceuticals announced on September 8, 2026 that the FDA has granted Rare Pediatric Disease Designation for the company's lead asset, QRX003, for the treatment of Peeling Skin Syndrome.¹

This marks the drug's second such designation. This is the second RPD designation granted for QRX003, following the previously granted RPD designation for Netherton Syndrome.¹ The RPD program exists to encourage development of new therapies for serious and life-threatening diseases that primarily affect people under 18 years old.¹

Quoin noted that if a New Drug Application for QRX003 is approved, the company may qualify for a Priority Review Voucher, which can be redeemed for priority review of another marketing application or sold or transferred.¹

CEO Michael Myers said the company is preparing next steps for the program. he said the Quoin team is preparing to start a Phase 2 study before the end of the year, planning to enroll up to 12 pediatric and adult Peeling Skin patients across the U.S. and Europe, calling it the first formal study conducted in the U.S. for this disease under an open IND.¹

On the disease itself, Quoin described Peeling Skin Syndrome as a rare autosomal recessive genodermatosis caused by loss-of-function variants of the corneodesmosin gene, resulting in excessive shedding of the superficial layers of the epidermis.¹ The company added that there is currently no approved treatment for PSS.¹

Quoin describes its pipeline as targeting a range of rare and orphan skin and vascular conditions beyond PSS and Netherton Syndrome, based on its two core platform products, QRX003 and QRX009.