11 March 2026 - Quoin Pharmaceuticals today announced that the US FDA has granted fast track designation to QRX003 lotion (4%) for the treatment of Netherton syndrome, a rare and severe genetic skin disorder for which there are currently no approved treatments.
QRX003 previously received orphan drug designation from both the US FDA and the EMA for the treatment of Netherton syndrome, providing potential benefits including market exclusivity upon approval, tax credits for clinical testing, and certain regulatory fee reductions. QRX003 has also been granted paediatric rare disease designation by the FDA.