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Quoin Pharmaceuticals, Ltd.
QNRXHealthcareNASDAQUS
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-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. FDA, and Orphan Drug Designation previously granted by the European Medicines Agency- -Quoin is working closely with leading Japanese clinicians to refine clinical and regulatory pathway for approval- ASHBURN, Va., June 04, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd.
-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- ASHBURN, Va., June 02, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd.
- 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. FDA Granted Fast Track Designation to QRX003 lotion (4%) for the treatment of Netherton Syndrome, Complementing Previously Granted Orphan Drug and Rare Pediatric Disease Designations - Constructive Type C Meeting with FDA: Single Phase 3 Study May Be Sufficient to Support U.
– 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. FDA Granted Fast Track Designation to QRX003 lotion (4%) for the treatment of Netherton Syndrome, Complementing Previously Granted Orphan Drug and Rare Pediatric Disease Designations – Constructive Type C Meeting with FDA: Single Phase 3 Study May Be Sufficient to Support U.S. Marketing Approval; FDA Open to Trial Design Without Traditional Vehicle or Placebo Control – Rare Pediatric Disease Priority Review Voucher Program Extended by Congress Through September 30, 2029 – On Track to Complete Phase 3 Patient Recruitment by End of 2026, with Potential NDA Filing in 2027 for QRX003 as the First Approved Treatment for Netherton Syndrome ASHBURN, Va., May 07, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd.
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 results for the first quarter ended March 31, 2026, before the market opens on Thursday, May 7, 2026.
Company Planning Multi-Pronged Approach for QRX009 Including Several Investigator Led Clinical Studies in Key Indications.
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 Leader in Pachyonychia Congenita Quoin Also Planning to Initiate Investigator Led Studies in Gorlin Syndrome and Tuberous Sclerosis Complex In addition to the Investigator Led Studies Company is Targeting to File Investigational New Drug Application to US Food and Drug Administration for QRX009 for an additional indication in Q3 2026 Quoin has Established Relationships With Key Advocacy Foundations including The PC Project and The Gorlin Syndrome Alliance as well as with Leading KOLs and Clinicians ASHBURN, Va.
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 and complete Phase 3 patient recruitment in 2026 and potentially file for NDA approval in 2027 ASHBURN, Va., March 25, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd.
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 results for the fourth quarter and full year ended December 31, 2025, before the market opens on Thursday, March 26, 2026.
— Fast Track Designation facilitates development and expedites regulatory review of therapies addressing serious conditions with significant unmet medical need —
