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Quoin Pharmaceuticals Earns European Orphan Drug Status for QRX003

MixedMedium impact
QNRX$4.15 −4.82%

Quoin Pharmaceuticals Ltd. (QNRX) has received Orphan Drug Designation from the European Medicines Agency for its drug candidate QRX003, which targets Peeling Skin Syndrome. Following the decision, the company plans to launch the first formal clinical study for the skin condition before the end of the year.

The orphan designation provides key incentives in Europe, including scientific guidance, reduced regulatory fees, access to European Union grants, and ten years of market exclusivity if the drug achieves full approval. QRX003 already holds Fast Track and rare pediatric disease designations in the United States.

Investors will monitor the upcoming clinical trial kickoff before year-end. Shares of Quoin Pharmaceuticals Ltd. were down 4.82% at $4.15 following the announcement.

Key points

  • The European Medicines Agency granted Orphan Drug Designation to QRX003 for Peeling Skin Syndrome.
  • Quoin Pharmaceuticals plans to initiate the first formal clinical study for Peeling Skin Syndrome before year-end.
  • European orphan status provides fee reductions, scientific advice, grant access, and potential ten-year market exclusivity.
  • QRX003 also carries Fast Track and pediatric rare disease designations in the United States.

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Questions and answers

What regulatory status did Quoin Pharmaceuticals receive in Europe?

The European Medicines Agency granted Orphan Drug Designation to QRX003 for treating Peeling Skin Syndrome.

What benefits does Orphan Drug Designation provide for QRX003?

The designation offers scientific advice, fee reductions, grant access, and ten years of European Union market exclusivity upon approval.

When will Quoin Pharmaceuticals start its trial for Peeling Skin Syndrome?

Quoin Pharmaceuticals plans to launch the first formal clinical study for Peeling Skin Syndrome before the end of the year.