QRX003

September 08, 2026: Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) said the FDA granted Rare Pediatric Disease designation to QRX003 for Peeling Skin Syndrome (PSS). Quoin said this is the second RPD designation for QRX003, following a prior designation in Netherton Syndrome.

The company said that if an NDA for QRX003 in PSS is approved, it may receive a freely tradable Priority Review Voucher. Quoin also noted the possibility of two PRVs across the two indications.

Upcoming catalyst: Quoin said FDA has cleared the IND for QRX003 in PSS and the company is preparing to start a Phase 2 study before the end of 2026, with enrollment of up to 12 pediatric and adult PSS patients in the U.S. and Europe. The release states there are currently no approved treatments for PSS.

PSS is described as a rare autosomal recessive genodermatosis caused by loss-of-function variants in CDSN, leading to excessive shedding of the superficial epidermis, severe pain, and chronic itch.