Quoin Pharmaceuticals Gains EMA Orphan Drug Status for QRX003
Quoin Pharmaceuticals Ltd. (QNRX) has secured Orphan Drug Designation from the European Medicines Agency for its drug candidate QRX003, aimed at treating Peeling Skin Syndrome. Shares of the company traded down 4.82% to $4.15 following the announcement.
The orphan designation provides regulatory incentives in Europe, including 10 years of potential market exclusivity in the European Union if the therapy secures final approval. QRX003 is also undergoing late-stage trials for Netherton Syndrome and holds Fast Track and Priority Review designations in the United States.
Investors will monitor the start of the first formal clinical trial for Peeling Skin Syndrome, which is scheduled to launch before the end of the year.
Key points
- European Medicines Agency granted Orphan Drug Designation to QRX003 for Peeling Skin Syndrome.
- The designation offers 10 years of EU market exclusivity if the drug is approved.
- Quoin Pharmaceuticals plans to initiate the first formal Peeling Skin Syndrome clinical trial before year-end.
- Shares of Quoin Pharmaceuticals fell 4.82% to $4.15.
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How we writeDisclaimerQuestions and answers
What is the new EMA status for Quoin Pharmaceuticals QRX003?
The European Medicines Agency granted QRX003 Orphan Drug Designation to treat Peeling Skin Syndrome.
What benefits does EMA Orphan Drug Designation provide QRX003?
If approved in the European Union, QRX003 will receive 10 years of market exclusivity alongside regulatory incentives.
When will Quoin Pharmaceuticals start clinical trials for Peeling Skin Syndrome?
Quoin Pharmaceuticals expects to begin the first formal clinical trial for Peeling Skin Syndrome before the end of the year.