Quoin says FDA grants rare pediatric disease designation for QRX003 in peeling skin syndrome - QNRX News | RalliesQuoin says FDA grants rare pediatric disease designation for QRX003 in peeling skin syndrome
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QNRX• Development timeline
- Quoin expects to start a Phase 2 study in 2H 2026, enrolling up to 12 pediatric and adult patients in the U.S. and Europe.
FDA designation and voucher potential
- FDA granted Rare Pediatric Disease designation for QRX003 in Peeling Skin Syndrome, extending a prior designation in Netherton Syndrome.
- An approved NDA for Peeling Skin Syndrome could qualify QRX003 for a Priority Review Voucher that can be sold or transferred.
- Management estimated two potential vouchers could exceed $300 million in aggregate non-dilutive value, based on recent trading levels.
