Recent Updates — QNRX
The European Medicines Agency has granted Orphan Drug Designation to Quoin Pharmaceuticals' lead product candidate, QRX003, for the treatment of Peeling Skin Syndrome. This designation provides incentive benefits including scientific advice on study protocols, fee reductions, and access to EU grants. If approved for marketing by the EMA, QRX003 will receive 10 years of market exclusivity in Europe for this indication. The company intends to initiate the first-ever formal clinical study for Peeling Skin Syndrome before year-end. Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases.
On September 22, 2026, Quoin Pharmaceuticals Ltd. announced that the U.S. Food and Drug Administration granted Fast Track Designation to QRX003 for the treatment of Peeling Skin Syndrome. This is the first such designation for a therapy targeting this rare genetic skin disease, which currently has no approved treatments. It marks the second indication for which QRX003 received Fast Track status, following Netherton Syndrome designated in March 2026. The designation follows FDA clearance of Quoin's Investigational New Drug application in July 2026. The company expects to initiate a Phase 2/3 clinical study enrolling up to 12 patients in the second half of 2026, targeting potential approval by 2028. Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases.
On September 8, 2026, Quoin Pharmaceuticals Ltd. announced that the U.S. Food and Drug Administration granted Rare Pediatric Disease Designation for its lead asset, QRX003, to treat Peeling Skin Syndrome. This marks the second such designation for QRX003, following a prior grant for Netherton Syndrome. The company stated it expects to initiate a Phase 2 clinical study before the end of 2026, planning to enroll up to 12 pediatric and adult patients in the U.S. and Europe under an open Investigational New Drug application. Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products for rare and orphan diseases.
Quoin Pharmaceuticals announced a private placement raising up to $50.0 million in gross proceeds, comprising an initial $30.8 million and up to $19.2 million from the potential cash exercise of accompanying warrants. The company issued 6,305,300 American Depositary Shares (ADSs) or pre-funded warrants at a combined price of $4.88 per unit, alongside ordinary warrants exercisable at $6.10 per ADS for up to 3,152,650 additional ADSs. Net proceeds are expected to fund operations into the second half of 2029. Additionally, Quoin reported positive interim Phase 2/3 data for QRX003 in Netherton Syndrome, where four of six participants met the primary endpoint with statistical significance (p=0.0087). The company also settled approximately $1.15 million in accrued debt by issuing 222,574 ADSs to note holders. Quoin Pharmaceuticals is a late clinical-stage specialty pharmaceutical company focused on developing treatments for rare and orphan diseases.