ASHBURN, Va. — Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (“Quoin” or the “Company”), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced that it has filed an application for Breakthrough Medicine Designation with the Saudi Food and Drug Authority (SFDA) for QRX003, its lead investigational, late-stage topical product candidate for the treatment of Netherton Syndrome.
The SFDA’s Breakthrough Medicine Designation program is designed to expedite the development, review, and potential availability of medicines that address serious or life-threatening conditions with high unmet medical need and which meet SFDA eligibility requirements, which include:
- Targets serious debilitating or life-threatening conditions with unmet medical need.
- The medicinal product is likely to offer major advantages over methods currently used.
- The potential adverse effects of the medicinal product are considered to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit/risk balance.
- The product is not registered with any regulatory authority at the time of submission of the designation request.
Quoin believes that QRX003 meets each of these eligibility requirements.
If granted, the designation will allow for accelerated regulatory review and could enable earlier patient access in Saudi Arabia, potentially as early as 2H 2026.
QRX003 has received Orphan Drug and Pediatric Rare Disease Designations from the U.S. Food and Drug Administration and Orphan Drug Designation from the European Medicines Agency for the potential treatment of Netherton Syndrome. Quoin has an established distribution partnership with Genpharm for QRX003 for Saudi Arabia and other MENA countries.
“Filing for Breakthrough Medicine Designation with the SFDA marks a historic milestone for both Quoin and the Netherton Syndrome community,” said Dr. Michael Myers, Chief Executive Officer of Quoin Pharmaceuticals. “If granted, it is possible that QRX003 could be available for sale and reimbursement in Saudi Arabia in the second half of this year. This would make QRX003 the first ever approved treatment anywhere in the world for this devastating disease. We look forward to working with our commercial partner in the region to make QRX003 available to Netherton patients in Saudi Arabia as expeditiously as possible, if the designation is granted.”
QRX003 lotion (4%) is currently being evaluated in two late-stage whole-body pivotal clinical trials in patients with Netherton Syndrome. Enrollment in both studies is expected to be completed in the first half of 2026, with top-line data anticipated in the second half of 2026. Quoin plans to submit a New Drug Application (NDA) in the United States and other territories in late 2026/early 2027, subject to successful clinical outcomes.
About Quoin Pharmaceuticals Ltd.
Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin’s innovative pipeline comprises three products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. For more information, visit www.quoinpharma.com or LinkedIn for updates.
For further information, contact:
Quoin Pharmaceuticals Ltd.
Michael Myers, Ph.D., CEO
[email protected]
Investor Contact:
PCG Advisory
Jeff Ramson
[email protected]
(646) 863-6341