Quoin reports positive interim QRX003 data, PSS designations, and Q3 2026 results
The company said its Netherton Syndrome study hit statistical significance on primary and key secondary endpoints as it advanced QRX003 into Peeling Skin Syndrome and closed a private placement of up to $50 million.
Quoin Pharmaceuticals reported on November 5, 2026 that an interim analysis of its Phase 2/3 study of QRX003 4% lotion in Netherton Syndrome, announced August 28, 2026, showed four of six participants, or 66.7%, who completed 12 weeks of treatment reaching the primary endpoint of at least a one-grade improvement in Investigator Global Assessment, with a p-value of 0.0087 against a pre-specified alpha of 0.0215.1 The key secondary endpoint, a Global Statistical Test of Global Impression of Change, also reached significance at Week 12, with a p-value of 0.0070 versus the same 0.0215 alpha.1 All three participants with moderate to severe pruritus at baseline saw at least a three-grade improvement on the Worst Itch Numeric Rating Scale by Week 12, including one participant who improved by more than six grades.1 No treatment-related serious adverse events occurred, and Quoin said it expects to finish enrolling all 20 participants by the end of 2026 and report topline results in the second quarter of 2027.1
On the regulatory side, the FDA cleared Quoin's IND for QRX003 in Peeling Skin Syndrome on July 9, 2026, the first IND ever submitted for that disease.1 The agency followed with Rare Pediatric Disease designation on September 8 and Fast Track designation on September 22, 2026, the latter being the first Fast Track designation ever granted for a PSS therapy.1 The European Medicines Agency then granted Orphan Drug Designation for QRX003 in PSS on October 14, 2026, which would carry ten years of EU market exclusivity if approved.1 The planned PSS Phase 2/3 study, the first company-sponsored formal trial in the disease, is expected to enroll up to 12 patients in the US and Europe and begin before year-end 2026.1
On financing, Quoin announced on August 28, 2026 a private placement of up to approximately $50 million, including about $30.8 million upfront and up to $19.2 million more from potential warrant exercises.1 The company held about $33.2 million in cash, cash equivalents, and marketable securities as of September 30, 2026.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.