Announcement • Aug 07
Quoin Pharmaceuticals, Ltd. to Report Q2, 2026 Results on Aug 14, 2026 Quoin Pharmaceuticals, Ltd. announced that they will report Q2, 2026 results Pre-Market on Aug 14, 2026 Announcement • Jul 09
Quoin Pharmaceuticals Receives FDA IND Clearance to Initiate Phase 2 Study of QRX003 in Peeling Skin Syndrome Quoin Pharmaceuticals Ltd. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for QRX003 for the treatment of Peeling Skin Syndrome (PSS), enabling initiation of its planned Phase 2 clinical study. Clearance enables Quoin to initiate a Phase 2 clinical study of QRX003 in Peeling Skin Syndrome in the second half of 2026. The study is expected to enroll 6-8 pediatric and adult patients in the United States and Europe. The IND is the first ever submitted to the FDA for Peeling Skin Syndrome, and its clearance now enables the first company-sponsored formal clinical study for the disease to be conducted. PSS is the second IND cleared indication for QRX003, in addition to Netherton Syndrome. In an ongoing investigator-led pediatric study, subject achieved clinically meaningful improvements by 12 weeks across key objective severity endpoints Modified Ichthyosis Area Severity Index (M-IASI), Investigator’s Global Assessment (IGA) and a pediatric dermatology-specific quality-of-life measure (CDLQI). Treatment is ongoing and after continued dosing with QRX003 for over 15 months, no adverse events have been reported. FDA expressed no safety concerns regarding study design and duration of dosing. Quoin submitted the IND on June 2, 2026, and received FDA clearance in July 2026. The Phase 2 study is expected to recruit 6-8 pediatric and adult patients with PSS in both the United States and Europe. In the Phase 2 study, QRX003 will be applied twice-daily to greater than 80% of the patients’ body surface area (BSA) over a 52-week period. The Company is targeting the approval of QRX003 as a potential treatment for PSS in 2028. Generalized inflammatory peeling skin syndrome (PSS) is a rare autosomal recessive genodermatosis caused by loss-of-function disease-causing variants of the corneodesmosin gene (CDSN), resulting in excessive shedding of the superficial layers of the epidermis. Patients generally suffer from a variety of conditions including severe pain and chronic pruritus (itch). There is currently no approved treatment for PSS. QRX003 is an investigational topical serine protease inhibitor lotion in late-stage development for Netherton Syndrome and other orphan skin diseases. QRX003 has been granted Orphan Drug, Rare Pediatric Disease, and Fast Track designations by the U.S. Food and Drug Administration, and Orphan Drug Designation in the European Union and Japan for Netherton Syndrome. QRX003 lotion (4%) is currently being evaluated in Phase 2 whole-body clinical trials in patients with Netherton Syndrome. Quoin’s pivotal Phase 3 study is expected to initiate in the second half of 2026, with a potential NDA filing in 2027. QRX003 is also being evaluated for the treatment of Peeling Skin Syndrome. Announcement • Jul 07
Quoin Pharmaceuticals, Ltd., Annual General Meeting, Aug 20, 2026 Quoin Pharmaceuticals, Ltd., Annual General Meeting, Aug 20, 2026. Location: at the offices of blank rome llp, one logan square, pa 19103., philadelphia United States