Quoin Expects to Initiate Phase 2 Study in 2H 2026, Study Plans to Enroll 6-8 Pediatric and Adult Patients in the U.S. and Europe FDA Expressed No Safety Concerns Over Study Design and Duration of Dosing First-Ever Formal Clinical Study for a Potential Peeling Skin Syndrome Therapy Second Cleared
Allowed Claims Cover a Method of Treating Netherton Syndrome with a Topical Serine Protease Inhibitor and an Anti-Inflammatory Agent, Including in Patients with SPINK5 Mutations ASHBURN, Va., June 30, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (“Quoin” or the “Company”), a
QRX003 Holds Orphan Drug Designation in the United States, the European Union, and Japan, Plus Fast Track and Rare Pediatric Disease Designations from the FDA Pivotal Phase 3 Study Expected to Initiate in the Second Half of 2026, with Potential NDA Filing in 2027 Positive Clinical Update from
Supports Quoin’s planned direct commercialization of QRX003 in Japan, one of its three core commercial territories Follows recent grant of Orphan Drug Designation to QRX003 by Japan’s MHLW ASHBURN, Va., June 18, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd.
Four of Six Patients Participating in the Compassionate Use Program Were Classified as ‘Improved’ or ‘Significantly Improved’ from Baseline Assessment Across Key Clinical Endpoints All Six Patients Are Younger than 10 Years of Age, with the Youngest Being Just 6 Months Old Duration of Treatment
-Designation provides regulatory and development incentives in Japan, including up to 10 years of market exclusivity upon approval- -Follows Orphan Drug Designation, Pediatric Rare Disease Designation, and Fast Track Designation previously granted by the U.S.
-First ever IND submission for this disease, which has no current treatment or cure- -Quoin plans Phase 2 study initiation in 2H 2026- -Submission supported by positive initial clinical data from Investigator-led pediatric study- -Second indication for QRX003, in addition to Netherton Syndrome-
– Filed Breakthrough Medicine Designation Application with Saudi FDA for QRX003 in Netherton Syndrome – Submitted Application to Japanese MHLW for Orphan Drug Designation (ODD) for QRX003; MHLW Confirmed QRX003 Qualifies for Both Orphan Drug Designation and Fast Track Review – U.S.
ASHBURN, Va., April 30, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the "Company" or "Quoin"), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced that it plans to provide a corporate update and release its financial
Company Planning Multi-Pronged Approach for QRX009 Including Several Investigator Led Clinical Studies in Key Indications. Company to Initiate Investigator Led Clinical Study in Pachyonychia Congenita Study Will be Led By Professor Edel O’Toole, Queen Mary University of London, Globally Recognized
– Closes Private Placement Financing of Up to $104.5 Million – Secures Orphan Drug Designations for QRX003 for Netherton Syndrome (NS) in the U.S. and Europe – Advances Proposed Expedited Regulatory Approval Pathways in Japan and Saudi Arabia and Secures Fast Track Designation in the U.S.
FDA indicated that a single Phase 3 study may be sufficient to support marketing approval in the U.S. FDA expressed openness to an alternative study design for Phase 3 that would likely not include a traditional upfront vehicle or placebo control Quoin remains on track to initiate a Phase 3 study
ASHBURN, Va., March 19, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the "Company" or "Quoin"), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced that it plans to provide a corporate update and release its financial
— Fast Track Designation facilitates development and expedites regulatory review of therapies addressing serious conditions with significant unmet medical need — — QRX003 lotion (4%) currently being evaluated in two late-stage whole-body clinical trials for treatment of Netherton Syndrome — — Fast
Videos on the NETHERTON NOW website have been viewed 2 million times with 24 million impressions ASHBURN, Va., Feb. 26, 2026 (GLOBE NEWSWIRE) -- In recognition of Rare Disease Day® 2026, Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) today highlighted the continued growth of its NETHERTON NOW awareness
Confirmation Received from MHLW That QRX003 Qualifies for Both Orphan Drug Designation and Fast Track Regulatory Review Status Quoin Initiating the Establishment of a Japanese Subsidiary to Facilitate Self-Commercialization of QRX003 in Japan, if Approved Orphan Drug Designation Previously Granted
If granted, QRX003 could be approved for sale and reimbursement in Saudi Arabia as a treatment for Netherton Syndrome in 2H 2026 QRX003 could become the first ever approved treatment for Netherton Syndrome ASHBURN, Va. , Jan. 20, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd.