--- title: "EMA grants orphan drug designation for QRX003 in peeling skin syndrome" url: "https://aibio.space/news/ema-grants-orphan-drug-designation-qrx003-peeling-skin-syndrome/" publisher: "aibio.space (Biotech Investor Relations News)" date: "2026-10-14" section: "Company Updates" tickers: "NASDAQ:QNRX" source: "https://www.sec.gov/Archives/edgar/data/1671502/000110465926115709/tm2627548d1_ex99-1.htm" summary: "The designation is the eighth regulatory milestone for QRX003, according to the company. If QRX003 is approved in the EU, it would receive 10 years of mark" --- By the aibio.space news desk. Sources - [Quoin Pharmaceuticals, Ltd. 8-K (2026-10-14)](https://www.sec.gov/Archives/edgar/data/1671502/000110465926115709/tm2627548d1_ex99-1.htm) - [Quoin Pharmaceuticals, Ltd. 10-K (2026-03-26): business](https://www.sec.gov/Archives/edgar/data/1671502/000110465926035251/qnrx-20251231x10k.htm) - [Quoin Pharmaceuticals, Ltd. financial data (SEC XBRL)](https://www.sec.gov/Archives/edgar/data/1671502/000110465926035251/) [QNRX](https://aibio.space/companies/quoin-pharmaceuticals/) 2026-10-14 # EMA grants orphan drug designation for QRX003 in peeling skin syndrome Tickers [QNRX](https://aibio.space/companies/quoin-pharmaceuticals/) The designation is the eighth regulatory milestone for QRX003, according to the company. If QRX003 is approved in the EU, it would receive 10 years of market exclusivity. ## Key facts - **Company**: Quoin Pharmaceuticals, Ltd. (NASDAQ: QNRX) - **News type**: Company Updates - **Primary source**: [Quoin Pharmaceuticals, Ltd. 8-K (2026-10-14)](https://www.sec.gov/Archives/edgar/data/1671502/000110465926115709/tm2627548d1_ex99-1.htm) *An inverted microscope in use. Public domain, via Wikimedia Commons. The picture shows the field, not the companies named.* Quoin Pharmaceuticals Ltd. (NASDAQ: [QNRX](https://aibio.space/companies/quoin-pharmaceuticals/)) said on October 14, 2026 that the European Medicines Agency had granted Orphan Drug Designation to QRX003 for the treatment of Peeling Skin Syndrome. The release says the designation gives the company incentive benefits, including scientific advice on study protocols, various fee reductions and access to EU grants. If the EMA approves QRX003 for marketing, it would receive 10 years of market exclusivity in Europe with respect to similar medicines for Peeling Skin Syndrome. ## The regulatory record The company describes the EMA designation as the eighth important regulatory milestone for QRX003. The release counts four Orphan Drug designations granted by three major regulatory agencies across both indications. It also counts two Pediatric Rare Disease Designations from the FDA, and Fast Track Designation from the FDA for both Netherton Syndrome and Peeling Skin Syndrome. For Netherton Syndrome, the release says QRX003 has Orphan Drug Designation in the United States, Europe and Japan. It also has Pediatric Rare Disease and Fast Track Designations in the United States. Chief Executive Dr. Michael Myers said: "We are on track to initiate the first-ever formal clinical study for Peeling Skin Syndrome, a severe rare skin disease that has long been underserved." The company says it expects to start that study before the end of 2026. ## The late-stage program QRX003 is also in late-stage clinical trials for Netherton Syndrome. The release describes the Netherton program as one in which there are currently no approved therapies. Quoin's pipeline comprises four products in development, which the company says collectively have the potential to target a broad number of rare and orphan indications. The release names Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa, Microcystic Lymphatic Malformations, Venous Malformations and Angiofibroma among them. Quoin's annual report for 2025, filed March 26, 2026, describes QRX003 as entering pivotal registrational clinical testing under an open Investigational New Drug application with the FDA. The report says the company has opened six clinical sites in the United States. It also describes nine commercial partnerships for QRX003 spanning 61 countries outside Quoin's core territories of the United States, Western Europe and Japan. ## Financial position The annual report shows research and development expense of $9.8 million for 2025, up from $3.6 million for 2024. It reports a net loss of $15.8 million for 2025 and $9.0 million for 2024. Cash from operations was negative $13.5 million in 2025 and negative $7.9 million in 2024. The release describes Quoin as a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. ## What the designation does not mean An orphan designation is a regulatory status, not a finding that QRX003 works. The release reports no efficacy or safety data for Peeling Skin Syndrome, and the first formal study in that disease has not started; the company says only that it is on track to begin before the end of 2026. The 10-year European exclusivity applies only if the EMA approves a marketing authorization, and the release gives no date for one. The count of eight regulatory milestones is the company's own, and it includes designations that do not change what the drug has shown in patients. The company says in its annual report that no products have been commercialized and no revenue has been generated. Cash used in operations was $13.5 million in 2025, against cash and cash equivalents of $3.8 million and short-term investments of $7.0 million at June 30, 2026. It also discontinued its QRX007 program for Netherton Syndrome in July 2025. [Report an error](https://aibio.space/reputation/#correction) ## Companies in this story QNRX Quoin Pharmaceuticals, Ltd. 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Cite as: aibio.space, "EMA grants orphan drug designation for QRX003 in peeling skin syndrome", 2026-10-14, https://aibio.space/news/ema-grants-orphan-drug-designation-qrx003-peeling-skin-syndrome/