FDA присвоила QRX003 статус лечения синдрома шелушащейся кожи

Quoin Pharmaceuticals Ltd. (QNRX) announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) Designation to QRX003 for the treatment of Peeling Skin Syndrome (PSS). The designation marks the second RPD designation granted to QRX003, following the FDA's previous designation for the candidate in Netherton Syndrome. The FDA's RPD program is intended to encourage the development of therapies for serious and life-threatening diseases that primarily affect individuals under 18 years of age. If a New Drug Application (NDA) for QRX003 is approved for PSS, Quoin may qualify to receive a Priority Review Voucher (PRV), which can be used to obtain priority review for another marketing application or sold or transferred. Quoin said the potential two PRVs associated with QRX003's RPD designations could have an aggregate non-dilutive cash value exceeding $300 million based on current PRV trading values. With the IND already cleared by the FDA, Quoin expects to initiate a Phase 2 clinical study of QRX003 in PSS in the second half of 2026. The planned Phase 2 study is expected to enroll up to 12 pediatric and adult patients with PSS in the United States and Europe. Quoin said the study would be the first formal clinical study conducted in the United States for PSS under an open IND. PSS is a rare autosomal recessive skin disorder caused by disease-causing variants in the corneodesmosin (CDSN) gene, resulting in excessive shedding of the superficial layers of the epidermis. Patients with PSS can experience severe pain and chronic pruritus, and there are currently no approved treatments for the condition. QRX003 is Quoin's lead development program and is being evaluated across multiple rare and orphan skin disorders, including Netherton Syndrome and Peeling Skin Syndrome. Quoin Pharmaceuticals is a late clinical-stage specialty pharmaceutical company focused on developing therapies for rare and orphan diseases. Its pipeline includes QRX003 and QRX009, targeting a range of rare conditions including Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin Syndrome, Tuberous Sclerosis Complex, Microcystic Lymphatic Malformations, Venous Malformations and Angiofibromas. Currently, QNRX Shares are trading at $7.28, up 0.28%. For comments and feedback contact: [email protected] Business News September 11, 2026 16:26 ET Consumer prices data was the main news on the economic front in the U.S. this week. In Europe, the latest interest rate decision from the European Central Bank was the focus along with the revised second quarter economic growth data for the euro area. In Asia, the monthly foreign trade data from China drew attention.