Rare and orphan diseases treatment

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Quoin Pharmaceuticals to Announce Second Quarter 2025 Financial Results on Thursday, August 7, 2025
Globenewswire· 2025-07-31 12:30
Core Viewpoint - Quoin Pharmaceuticals Ltd. is set to release its financial results for Q2 2025 on August 7, 2025, which will include operational updates and financial highlights [1][2]. Company Overview - Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products for rare and orphan diseases [3]. - The company aims to address unmet medical needs for patients and their communities [3]. - Quoin's pipeline includes four products in development targeting various rare and orphan indications such as Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, and Epidermolysis Bullosa [3].
Quoin Pharmaceuticals Provides Product Portfolio Update
GlobeNewswire· 2025-07-29 12:30
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]
Quoin Pharmaceuticals Announces FDA Clearance to Initiate Second Pivotal Whole Body QRX003 Netherton Syndrome Clinical Study
Globenewswire· 2025-05-22 11:30
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].
Quoin Pharmaceuticals Provides Corporate Update and Announces First Quarter 2025 Financial Results
Globenewswire· 2025-05-13 12:00
Q1 2025 Corporate Highlights Continued Progress in Ongoing Late-Stage Netherton Syndrome Studies Announced Positive Clinical Data for Adult and Pediatric Netherton Patients Provided Clear Visual Evidence of QRX003 Mechanism of Action Patent Portfolio Expanded to Support Pipeline Growth Launch of NETHERTON NOW Advocacy Initiative ASHBURN, Va., May 13, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the "Company" or "Quoin"), a late clinical-stage, specialty pharmaceutical company focused ...