Quoin Pharmaceuticals Receives Conditional FDA Approval for QYLEKI Brand Name
Quoin Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has conditionally approved QYLEKI™ as the proposed brand name for QRX003, its investigational product for Netherton Syndrome. This marks a significant milestone as the company progresses towards delivering the first approved treatment for the rare disease. QRX003 already holds Orphan Drug, Fast Track, and Rare Pediatric Disease Designations. The pivotal Phase 3 study is expected to begin in the second half of 2026, with a potential NDA filing in 2027.
Key Highlights
- FDA conditionally approved QYLEKI™ as the proposed brand name for QRX003.
- QRX003 holds Orphan Drug Designation in the US, EU, and Japan.
- FDA granted QRX003 Fast Track and Rare Pediatric Disease Designations.
- Pivotal Phase 3 study for QRX003 expected to initiate in H2 2026.
- Potential New Drug Application (NDA) filing anticipated in 2027.
- QRX003 aims to be the first approved treatment for Netherton Syndrome.
Price Impact
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