— Fast Track Designation facilitates development and expedites regulatory review of therapies addressing serious conditions with significant unmet medical need —

— QRX003 lotion (4%) currently being evaluated in two late-stage whole-body clinical trials for treatment of Netherton Syndrome —

— Fast Track Designation follows Pediatric Rare Disease and Orphan Drug Designation previously granted by the FDA and Orphan Drug Designation granted by the European Medicines Agency for QRX003 in Netherton Syndrome —

Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) ("Quoin" or the "Company"), a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to QRX003 lotion (4%) for the treatment of Netherton Syndrome, a rare and severe genetic skin disorder for which there are currently no approved treatments.

"We believe that the FDA's decision to grant Fast Track Designation to QRX003 reflects the urgent unmet need faced by patients and families living with Netherton Syndrome," said Dr. Michael Myers, CEO and Co-Founder of Quoin Pharmaceuticals. "Fast Track status enables more frequent communication with the FDA and the potential for accelerated regulatory review pathways, which may help bring the first approved treatment for Netherton Syndrome to patients as quickly as possible."

QRX003 Development Program

QRX003 lotion (4%) is currently being evaluated in two late-stage whole-body clinical trials designed to assess safety and efficacy in patients with Netherton Syndrome.

QRX003 previously received Orphan Drug Designation from both the U.S. FDA and the European Medicines Agency (EMA) for the treatment of Netherton Syndrome, providing potential benefits including market exclusivity upon approval, tax credits for clinical testing, and certain regulatory fee reductions. QRX003 has also been granted Pediatric Rare Disease Designation by the FDA.