Quoin Pharma gets FDA conditional approval of brand name QYLEKI for Netherton Syndrome candidate

Quoin Pharmaceuticals, Ltd.

FDA conditionally approved QYLEKI as proposed brand name for QRX003, an investigational treatment for Netherton Syndrome.
No approved treatment currently exists; QRX003 could become the first if approved.
Pivotal Phase 3 study expected to initiate in H2 2026; potential NDA filing in 2027.
QRX003 holds Orphan Drug Designations in US, EU, Japan; Fast Track and Rare Pediatric Disease Designations from FDA.
Positive clinical update from ongoing Pediatric Compassionate Use Program released June 16, 2026.

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