GlobeNewswire·Sep 8, 2026, 8:30 AM ET

Quoin Pharmaceuticals Announces FDA Grants Rare Pediatric Disease Designation for QRX003 in Peeling Skin Syndrome

FDA granted Rare Pediatric Disease (RPD) designation for QRX003 to treat Peeling Skin Syndrome (PSS), marking the second such designation for the asset after Netherton Syndrome.
Approval of a New Drug Application (NDA) for QRX003 in PSS could allow Quoin Pharmaceuticals to receive a Priority Review Voucher (PRV) eligible for sale or transfer.
CEO Dr. Michael Myers stated potential eligibility for two PRVs could yield an aggregate non-dilutive cash value exceeding $300 million.
Quoin plans to initiate a Phase 2 clinical study in the second half of 2026 with an open IND to enroll up to 12 pediatric and adult PSS patients in the U.S. & Europe.
Generalized inflammatory PSS is a rare autosomal recessive genodermatosis caused by CDSN gene variants, causing severe pain, chronic itch, & excessive epidermal shedding, with no currently approved treatments.
Quoin is a late clinical-stage company focused on rare diseases, with a pipeline including QRX003 & QRX009 targeting multiple indications such as Tuberous Sclerosis Complex & Venous Malformations.