Quoin Pharmaceuticals Announces European Medicines Agency (EMA) Grants Orphan Drug Designation for QRX003 for the Treatment of Peeling Skin Syndrome

The designation brings development incentives, with 10 years of European market exclusivity conditional on marketing approval.

Rhea-AI Summary

Quoin Pharmaceuticals (NASDAQ: QNRX) has received European Medicines Agency orphan drug designation for QRX003 to treat Peeling Skin Syndrome. The designation provides scientific advice on study protocols, fee reductions and access to EU grants. Marketing approval would confer 10 years of European market exclusivity against similar medicines for this condition.

Quoin expects to initiate a formal Peeling Skin Syndrome clinical trial before year-end 2026. QRX003 also holds US Pediatric Rare Disease and Fast Track designations for this condition. For Netherton Syndrome, it holds orphan drug designations in the US, Europe and Japan, plus US Pediatric Rare Disease and Fast Track designations, and is undergoing late-stage clinical trials.

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Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate point. Forward-looking: it has not happened yet and may not happen.Quoin expects to initiate a formal Peeling Skin Syndrome clinical trial before year-end 2026.
• Minor pointQRX003 received European orphan drug designation for Peeling Skin Syndrome, providing protocol advice, fee reductions and EU grant access.
• Minor point. Forward-looking: it has not happened yet and may not happen.QRX003 would receive 10 years of European market exclusivity for Peeling Skin Syndrome if approved for marketing.
• Minor pointQRX003 also holds US Pediatric Rare Disease and Fast Track designations for Peeling Skin Syndrome.
• Minor pointQRX003 holds US, European and Japanese orphan drug designations for Netherton Syndrome.
• Minor pointQRX003 holds US Pediatric Rare Disease and Fast Track designations for Netherton Syndrome.

Negative

• None.

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-1.11% vs previous close $4.10 last price 86.5x rel. volume Open Argus

Details

Market Reaction – QNRX

$4.01 – $4.79 Day Range

$8.24M Market Cap

On Oct 14, the day this news came out, the latest delayed price for QNRX is 1.11% below the previous close. Our momentum scanner has recorded 10 alerts for this stock so far that day. The latest delayed price is $4.10. Relative volume is exceptionally heavy at 86.5x the average.

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Key Figures

Market exclusivity: 10 years

Market exclusivity

10 years

Europe, conditional on marketing authorization for Peeling Skin Syndrome

Previous Clinical trial Reports

2 past events · Latest: Sep 22

Same Type 2 events

1. Sep 22

   Fast Track designation

   24h Move

   +1.9%

   FDA granted QRX003 Fast Track Designation for Peeling Skin Syndrome.

2. Jul 09

   IND clearance

   24h Move

   -1.1%

   FDA cleared QRX003's IND for a planned Phase 2 study in Peeling Skin Syndrome.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

orphan drug designation, marketing authorization, fast track designation, pediatric rare disease designation

4 terms

orphan drug designation regulatory

"granted Orphan Drug Designation in Europe"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

marketing authorization regulatory

"after receipt of marketing authorization in the European Union"

An official government approval that allows a drug, vaccine, or medical device to be sold and promoted in a specific country or region. Think of it as a safety and effectiveness passport issued after regulators review the product’s tests and manufacturing; for investors, receiving this authorization typically unlocks sales, revenue potential, and lower regulatory risk, while delays or denials can substantially affect a company’s value and timeline.

fast track designation regulatory

"granted Pediatric Rare Disease Designation and Fast Track Designation"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

pediatric rare disease designation regulatory

"granted Pediatric Rare Disease Designation and Fast Track Designation"

A pediatric rare disease designation is a formal regulatory status given to a drug or therapy aimed at a serious, uncommon illness that primarily affects children. It matters to investors because the designation often brings financial and timing advantages—such as development funding, tax breaks, faster review, or market protections—similar to getting a VIP pass that lowers costs and increases the chance of reaching patients and generating returns.

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– Company on track to initiate first-ever formal clinical trial in Peeling Skin Syndrome before year end 

– Orphan Drug designation milestone provides 10 years of market exclusivity for Peeling Skin Syndrome in Europe after receipt of marketing authorization in the European Union

– Designation Represents Eighth Important Regulatory Milestone for QRX003

– QRX003 has also been granted Pediatric Rare Disease Designation and Fast Track Designation for Peeling Skin Syndrome from US Food and Drug Administration

– In Netherton Syndrome, QRX003 has been granted Orphan Drug Designation in US, Europe and Japan as well as Pediatric Rare Disease and Fast Track Designations in the US

ASHBURN, Va., Oct. 14, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a late clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today announces that its lead product candidate QRX003 has been granted Orphan Drug Designation in Europe by the European Medicines Agency (EMA) for the treatment of Peeling Skin Syndrome.

Orphan Drug Designation in Europe affords the Company incentive benefits including scientific advice on study protocols, various fee reductions and access to EU grants. If approved for marketing by the EMA, QRX003 will be granted 10 years of market exclusivity in Europe with respect to similar medicines for the treatment of Peeling Skin Syndrome.

Quoin CEO, Dr. Michael Myers, said, “We continue to make important clinical and regulatory progress for QRX003, both as a potential treatment for Netherton Syndrome and Peeling Skin Syndrome, and this milestone marks yet another significant step forward for Quoin. Cumulatively across both indications, QRX003 has now been granted four Orphan Drug designations by three major regulatory agencies, two Pediatric Rare Disease Designations from the US FDA as well as Fast Track Status for both indications in the US. These eight important regulatory milestones reflect both the innovative nature of the product and the recognition of the unmet medical needs it is targeting. 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.”

QRX003 is also currently being evaluated in late-stage clinical trials for Netherton Syndrome, a severe and devastating, life-altering rare disease for which there are currently no approved therapies.

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 four 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, Epidermolysis Bullosa, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. For more information, visit: www.quoinpharma.com or LinkedIn for updates.

Cautionary Note Regarding Forward Looking Statements
The Company cautions that statements in this press release that are not descriptions of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances, such as “expect,” “intend,” “hope,” “plan,” “potential,” “anticipate,” “look forward,” “believe,” “may,” and “will,” among others. All statements that reflect the Company’s expectations, assumptions, projections, beliefs, or opinions about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements relating to: the Company being on track to initiate first-ever formal clinical trial in Peeling Skin Syndrome before year end; QRX003 as a potential treatment for Netherton Syndrome and Peeling Skin Syndrome; advancing QRX003 in Quoin’s late-stage Netherton Syndrome and Peeling Skin Syndrome clinical studies: upon marketing authorization being granted 10 years of market exclusivity in Europe for the treatment of Peeling Skin Syndrome, and Quoin’s products in development collectively having the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties including, but not limited to, the Company’s ability to pursue its regulatory strategy including initiating the first ever formal clinical trial in Peeling Skin Syndrome before year end; the Company’s ability to continue to meet the requirements for orphan drug designation and to obtain ten years of market exclusivity in Europe with respect to similar medicines for the treatment of Peeling Skin Syndrome; the Company’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements; the Company’s ability to complete clinical trials on time and achieve desired results and benefits as expected; and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and in other filings the Company has made and may make with the SEC in the future. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.

For further information, contact:

Quoin Pharmaceuticals Ltd.
Dr. Michael Myers, Ph.D., CEO
mmyers@quoinpharma.com 

Investor Relations
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com 
(646) 863-6341

FAQ

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What does European orphan drug designation mean for Quoin's QRX003 in Peeling Skin Syndrome?

The designation provides development incentives and, if QRX003 receives marketing approval, 10 years of European market exclusivity against similar medicines for Peeling Skin Syndrome. Incentives include scientific advice on study protocols, fee reductions and access to EU grants.

When does Quoin expect to start its QRX003 Peeling Skin Syndrome trial?

Quoin expects to initiate a formal clinical trial for Peeling Skin Syndrome before year-end 2026. The company describes the planned study as the first formal clinical trial for the condition.