– 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