ASHBURN, Va., Aug. 21, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (“Quoin” or the “Company”), a clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced that its NETHERTON NOW awareness campaign has surpassed a major milestone, achieving more than one million video views and over 14 million impressions. Launched to give patients, families, and experts a greater voice, NETHERTON NOW has become a global platform shining a spotlight on the pai ...

ASHBURN, Va., Aug. 18, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (“Quoin” or the “Company”), a late clinical stage specialty pharmaceutical company focused on rare and orphan diseases, today announced the appointment of its new Chief Financial Officer as the Company advances its lead product candidate, QRX003, through pivotal clinical studies and prepares for potential commercialization. Quoin has appointed Sally Lawlor, BCL, FCA, as its new Chief Financial Officer, effective immedi ...

New Episode Highlights the Painful, Often Misunderstood Reality of Living with Netherton Syndrome and the Urgent Need for Effective TreatmentsASHBURN, Va., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (“Quoin” or the “Company”), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced the release of the fourth episode in its NETHERTON NOW video series. This installment features Mandy Aldwin-Easton, a Netherton Syndrome patient ...

- Positive 6 Month Clinical Data Reported for Ongoing Pediatric Netherton Syndrome Study - FDA Clears Second Pivotal Study of QRX003 for Netherton Syndrome - Initial Positive Data Announced from Peeling Skin Syndrome Pediatric Study - Orphan Drug Designation Granted by European Medicines Agency for QRX003 - Rare Pediatric Disease Designation Awarded by U.S. FDA - NETHERTON NOW Campaign Expanded with New Patient and Expert Video Releases ASHBURN, Va., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals L ...

Core Insights - Quoin Pharmaceuticals is advancing its lead product QRX003 for Netherton Syndrome through two pivotal registrational clinical studies across the US, Europe, and the Middle East [2][3] - The company aims to file a New Drug Application (NDA) for QRX003 in the second half of 2026 and plans to self-commercialize the product in the US, Western Europe, and Japan [3] - Quoin has also reported positive initial data from a clinical study for Peeling Skin Syndrome (PSS), marking significant improvements in key clinical endpoints [4] Clinical Development - QRX003 is being tested in two studies, with over 80% of subjects' body surface area treated twice daily for 12 weeks [2] - The first study tests QRX003 as a monotherapy, while the second study combines it with off-label systemic therapy [2] - Each study is expected to recruit 12 to 16 subjects, with full recruitment targeted for early to mid Q1 2026 [2] Product Pipeline - Quoin's clinical program for QRX003 is on track to potentially become the first approved treatment for Netherton Syndrome [3] - The company has discontinued the development of QRX007 for Netherton Syndrome and QRX004 for Epidermolysis Bullosa, focusing resources on high-potential opportunities [6][7] - The topical rapamycin program is progressing, targeting rare skin diseases, with clinical testing anticipated to begin in the first half of 2026 [5] Market Strategy - Quoin has established nine commercial partnerships to support global access to QRX003 across 61 additional countries upon approval [3] - The company is transitioning into pre-commercialization mode in anticipation of the potential approval and launch of QRX003 within the next 18 to 24 months [7]

Core Insights - Quoin Pharmaceuticals has released a new episode in its NETHERTON NOW video series, highlighting the severe burden of Netherton Syndrome in infants and children and the need for effective pediatric treatments [1][4] - The U.S. FDA has granted Rare Pediatric Disease Designation for Quoin's lead product candidate, QRX003, which aims to address the serious and underserved nature of Netherton Syndrome in pediatric patients [3][4] Company Overview - Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, with a commitment to addressing unmet medical needs [6] - The company is developing a pipeline of four products targeting various rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, and others [6] Product Information - QRX003 is a topical lotion designed to promote a normalized skin-shedding process and strengthen the skin barrier in patients with Netherton Syndrome [5] - The mechanism of action for QRX003 involves a proprietary delivery technology that contains a broad-spectrum serine protease inhibitor, which mimics the function of a specific protein called LEKTI [5] Expert Insights - Professor Jemima Mellerio, a recognized authority in dermatology, emphasizes the life-threatening challenges of Netherton Syndrome and the critical need for improved therapeutic options [2][3] - The experiences shared by Professor Mellerio in the NETHERTON NOW series highlight the challenges faced by children and families living with this condition [4]

Core Viewpoint - Quoin Pharmaceuticals has received Rare Pediatric Disease Designation from the FDA for its lead asset QRX003, aimed at treating Netherton Syndrome, a rare genetic disorder affecting children [1][3][4] Company Overview - Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing treatments for rare and orphan diseases, with a pipeline that includes four products targeting various conditions [5] Regulatory Designations - The FDA's Rare Pediatric Disease Designation for QRX003 highlights its potential as a therapeutic candidate for an underserved pediatric population, following the Orphan Drug Designation granted by the EMA in May 2025 [2][3] Clinical Development - The company is focused on completing pivotal clinical studies for QRX003 and advancing it towards a New Drug Application (NDA) as the first potential treatment for Netherton Syndrome [3][5] Disease Background - Netherton Syndrome is a rare genetic disorder affecting approximately 1 in 200,000 newborns, with symptoms that can lead to severe skin inflammation and a mortality rate in infancy estimated at 10 to 20 percent [4]

Core Viewpoint - Quoin Pharmaceuticals has received FDA clearance to initiate a second pivotal clinical study for QRX003, targeting Netherton Syndrome, which is expected to generate comprehensive safety and efficacy data to support regulatory approval [1][3]. Group 1: Clinical Study Details - The new study, CL-QRX003-002, will involve approximately 12-15 subjects and will apply QRX003 to at least 80% of each subject's body surface area, enhancing the data collected compared to earlier studies [2][5]. - This pivotal study complements another ongoing study, CL-QRX003-003, where QRX003 is administered as monotherapy without off-label systemic therapy [2][5]. - Quoin anticipates recruiting between 24-30 subjects across 6 U.S. sites and up to 6 international sites, with recruitment expected to be completed by the end of Q1 2026 [2][5]. Group 2: Product and Market Potential - QRX003 is a topical lotion designed to downregulate the hyperactivity of kallikreins in the skin, addressing excessive skin shedding and associated symptoms in Netherton Syndrome patients [1][3]. - The combined data from both pivotal studies is expected to provide QRX003 with a broad label opportunity post-approval, allowing it to be used both as a monotherapy and in conjunction with off-label systemic treatments [5]. Group 3: Company Overview - Quoin Pharmaceuticals is a clinical-stage specialty pharmaceutical company focused on developing treatments for rare and orphan diseases, with a pipeline that includes products targeting various conditions such as Peeling Skin Syndrome and Epidermolysis Bullosa [4]. - The company is committed to addressing unmet medical needs for patients and their communities [4].

Core Viewpoint - Quoin Pharmaceuticals has received Orphan Drug Designation in Europe for its lead product QRX003, which is in late-stage clinical trials for treating Netherton Syndrome, providing the company with significant regulatory advantages and potential market exclusivity [1][2][3] Company Overview - Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing treatments for rare and orphan diseases, with a pipeline that includes four products targeting various conditions [4] Product Development - QRX003 is designed as a topical, non-systemic treatment for Netherton Syndrome, a severe disease with no current approved therapies, and is currently undergoing multiple late-stage clinical trials [3][4] - The product has shown promising clinical results, including significant skin healing and reduction of severe chronic pruritus in pediatric studies, indicating its potential efficacy as a broad-spectrum kallikrein inhibitor [3] Regulatory Milestones - The Orphan Drug Designation provides Quoin with benefits such as scientific advice on study protocols, fee reductions, and access to EU grants, and if approved, QRX003 will receive 10 years of market exclusivity in Europe [2][3]

Core Insights - Quoin Pharmaceuticals has released the second episode of its "Living with Netherton" video series, featuring the story of 79-year-old Norma Coles, who was diagnosed with Netherton Syndrome decades after her initial evaluation [1][2] - The campaign aims to raise awareness and support for individuals affected by Netherton Syndrome, highlighting the challenges faced by patients, including misdiagnosis and lack of treatment options [2][4] - Quoin's lead product candidate, QRX003, is currently undergoing clinical trials, with the goal of becoming the first FDA-approved treatment for Netherton Syndrome [5][6] Company Overview - Quoin Pharmaceuticals is a late clinical-stage specialty pharmaceutical company focused on developing treatments for rare and orphan diseases [1][7] - The company has a pipeline that includes four products targeting various rare conditions, including Netherton Syndrome, Peeling Skin Syndrome, and others [7] - Quoin is committed to addressing unmet medical needs and improving the quality of life for patients and their families [7] Product Development - QRX003 is a topical lotion designed to address the skin barrier issues associated with Netherton Syndrome by promoting a normalized skin-shedding process [6] - Initial data from ongoing clinical trials of QRX003 show promising results, including improvements in skin healing and reductions in inflammation and pruritus [5] - The company aims to complete the development of QRX003 to provide a transformative treatment option for patients who have long awaited effective therapies [5][6]