On September 8, 2026, the FDA granted QRX003 Rare Pediatric Disease Designation for Peeling Skin Syndrome, expanding the product candidate’s regulatory designations. For investors, an approved NDA could make Quoin eligible for a transferable Priority Review Voucher, while the company expects to begin a Phase 2 study before 2026 ends.

Key Highlights

  • FDA granted QRX003 Rare Pediatric Disease Designation for Peeling Skin Syndrome, its second RPD designation after Netherton Syndrome.
  • An approved NDA for QRX003 in Peeling Skin Syndrome could make Quoin eligible for a Priority Review Voucher.
  • Quoin expects to begin a Phase 2 Peeling Skin Syndrome study before the end of 2026 in the U.S. and Europe.

The designation applies to the company’s lead asset and addresses a condition for which the company says there are currently no approved treatments.

QRX003 Gains New FDA Designation

The FDA’s Rare Pediatric Disease program is intended to encourage development of therapies for serious, life-threatening diseases that mainly affect people under eighteen. QRX003 previously received the same designation for Netherton Syndrome, making the Peeling Skin Syndrome decision an additional RPD designation for the product candidate. The company also said its IND has been cleared by the FDA. Quoin (NASDAQ: QNRX) expects to start a Phase 2 clinical study before the end of 2026.

Potential Priority Review Voucher

The voucher could be redeemed for priority review of another Marketing application or sold or transferred. The company may qualify only if an NDA for QRX003 is approved. Peeling Skin Syndrome is described as a rare inherited skin disorder involving excessive shedding of superficial epidermal layers. Patients may experience severe pain and chronic itching, while approved treatment Options are currently unavailable.