The FDA recently granted QRX003 Rare Pediatric Disease (RPD) Designation for the treatment of NS. The European Medicines Agency earlier had granted Orphan Drug Designation to QRX003. The company believes these designations reinforce the potential of QRX003 as a therapeutic candidate as it advances clinical studies towards a potential New Drug Application (NDA) for QRX003 as the first approved treatment for NS. If an NDA for QRX003 is approved, Quoin may also be eligible for a Priority Review Voucher, which can be used to obtain faster review or it can be monetized by selling it to another company.

07 Aug 2025
QNRX: Recent FDA & EMA Designations for QRX003 Potentially Could Accelerate Timeline

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QNRX: Recent FDA & EMA Designations for QRX003 Potentially Could Accelerate Timeline
- Published:
07 Aug 2025 -
Author:
Marla Backer -
Pages:
12 -
The FDA recently granted QRX003 Rare Pediatric Disease (RPD) Designation for the treatment of NS. The European Medicines Agency earlier had granted Orphan Drug Designation to QRX003. The company believes these designations reinforce the potential of QRX003 as a therapeutic candidate as it advances clinical studies towards a potential New Drug Application (NDA) for QRX003 as the first approved treatment for NS. If an NDA for QRX003 is approved, Quoin may also be eligible for a Priority Review Voucher, which can be used to obtain faster review or it can be monetized by selling it to another company.