Quoin Pharmaceuticals Files for Breakthrough Medicine Designation in Saudi Arabia
Quoin Pharmaceuticals announced that it has filed an application for Breakthrough Medicine Designation with the Saudi Food and Drug Authority, SFDA, for QRX003. 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. "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."
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Quoin Pharmaceuticals Files for Breakthrough Designation for QRX003, Potential First Treatment for Netherton Syndrome
- Breakthrough Application: Quoin Pharmaceuticals has filed for Breakthrough Medicine Designation for QRX003 with the Saudi Food and Drug Authority, which, if granted, will expedite the review process and potentially allow early patient access by the second half of 2026, marking a historic milestone in the treatment of Netherton Syndrome.
- Clinical Trial Progress: QRX003 is currently undergoing two pivotal whole-body clinical trials, with enrollment expected to complete in the first half of 2026 and top-line data anticipated in the second half, providing critical evidence for subsequent drug applications and facilitating market entry.
- Significant Market Potential: If approved, QRX003 will be the first-ever treatment for Netherton Syndrome globally, and Quoin's distribution partnership with Genpharm will ensure its promotion in Saudi Arabia and other MENA countries, addressing the urgent need for rare disease therapies in the region.
- Regulatory Support Strengthened: QRX003 has received Orphan Drug and Pediatric Rare Disease Designations from the U.S. FDA and Orphan Drug Designation from the European Medicines Agency, indicating strong regulatory recognition worldwide and enhancing Quoin's competitive position in the rare disease market.
Quoin Pharmaceuticals Stock Rises 21% Following Topical Rapamycin Achievement
Stock Performance: Quoin Pharmaceuticals Ltd. (QNRX) saw a 21.15% increase in stock price, reaching $9.99, following the announcement of successful rapamycin loadings in their topical delivery platforms.
Clinical Development Plans: The company intends to manufacture clinical trial and stability batches in Q4 2025 and start clinical testing in the first half of 2026 for conditions like microcystic lymphatic malformations and venous malformations, which currently have no FDA-approved treatments.
Trading Activity: The announcement led to unusually high trading volume for QNRX, indicating strong investor interest in the company's developments.
Stock Range: The stock's 52-week price range is noted to be between $2.65 and $9.99.
