Core Viewpoint - Quoin Pharmaceuticals has applied for Breakthrough Medicine Designation for QRX003, which could become the first approved treatment for Netherton Syndrome in Saudi Arabia by the second half of 2026 [1][4]. Group 1: Product Development and Regulatory Status - QRX003 is a late-stage topical product candidate aimed at treating Netherton Syndrome and has received Orphan Drug and Pediatric Rare Disease Designations from the U.S. FDA and Orphan Drug Designation from the European Medicines Agency [3]. - The SFDA's Breakthrough Medicine Designation program aims to expedite the development and review of medicines addressing serious conditions with high unmet medical needs, and Quoin believes QRX003 meets these eligibility requirements [2][3]. - If granted, the designation will allow for accelerated regulatory review and could enable earlier patient access in Saudi Arabia, potentially as early as the second half of 2026 [3]. Group 2: Clinical Trials and Future Plans - QRX003 lotion (4%) is currently being evaluated in two late-stage pivotal clinical trials, with enrollment expected to be completed in the first half of 2026 and top-line data anticipated in the second half of 2026 [4]. - Quoin plans to submit a New Drug Application (NDA) in the United States and other territories in late 2026 or early 2027, contingent on successful clinical outcomes [4]. Group 3: Company Overview - Quoin Pharmaceuticals is a late clinical-stage specialty pharmaceutical company focused on developing treatments for rare and orphan diseases, with a pipeline that includes products targeting various rare conditions [5].