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ASHBURN, Va. - Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX), a specialty pharmaceutical company with a market capitalization of approximately $5 million, has received FDA clearance to initiate a pivotal clinical study for QRX003, a treatment for Netherton Syndrome (NS), according to a press release statement. According to InvestingPro analysis, the company maintains a healthy liquidity position with a current ratio of 2.57, indicating strong ability to meet short-term obligations. The study, CL-QRX003-002, will evaluate the efficacy of QRX003 when used in conjunction with off-label systemic therapy in approximately 12-15 subjects.
QRX003 is a topical lotion designed to combat the excessive skin shedding associated with NS by inhibiting the activity of kallikreins in the skin. Previous clinical trials have shown QRX003 to significantly alleviate symptoms such as chronic pruritus and sleep disturbances.
This new study will apply QRX003 to at least 80% of each subject’s body surface area, aligning with the intended real-world use of the lotion upon regulatory approval. Participants in this study are already undergoing off-label systemic therapy and will continue this treatment throughout the study duration.
The study complements another pivotal study, CL-QRX003-003, led by Dr. Amy Paller at Northwestern University, where QRX003 is tested as monotherapy without additional systemic treatments. Combined, both studies aim to recruit between 24-30 subjects across six U.S. sites and up to six international sites, with recruitment expected to conclude by the end of Q1 2026. The company’s stock has shown recent momentum, posting a 10% return over the past week, though InvestingPro data reveals significant potential upside based on its Fair Value analysis. Quoin plans to file a New Drug Application (NDA) for QRX003 later the same year.
Dr. Michael Myers, CEO of Quoin, expressed optimism about the potential of the combined data from both studies to support a broad label opportunity for QRX003 and to address the unmet medical needs of NS patients.
Quoin focuses on rare and orphan diseases, with a pipeline of products targeting conditions like Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, and Epidermolysis Bullosa. The company emphasizes its commitment to addressing the needs of patients and their care teams.
The press release includes forward-looking statements regarding the anticipated outcomes of the studies, recruitment timelines, and the potential regulatory approval process, which are subject to risks and uncertainties that could cause actual results to differ. While analyst price targets range from $50.40 to $350.00, investors should note that the company reported negative EBITDA of $10.93 million in the last twelve months. For deeper insights into Quoin’s financial health and growth prospects, including 8 additional ProTips and comprehensive analysis, visit InvestingPro.
In other recent news, Quoin Pharmaceuticals Ltd. has reported positive initial results from its clinical study on Pediatric Peeling Skin Syndrome using its investigational drug QRX003. The study revealed significant improvement in the patient’s skin condition after 12 weeks, with no adverse events reported. The company is also advancing QRX003 in late-stage clinical studies for Netherton Syndrome, where the treatment has shown to maintain nearly complete skin healing after six weeks. In related developments, Quoin Pharmaceuticals has regained compliance with Nasdaq’s minimum bid price requirement, receiving a notice confirming that its shares closed at or above $1.00 per share for 13 consecutive business days. Additionally, the company has announced a change in the ratio of its American Depositary Shares to meet Nasdaq’s requirements, effectively implementing a one-for-twenty reverse stock split. This adjustment aims to increase the per ADS market price to maintain its listing on the Nasdaq Capital Market. These developments reflect the company’s ongoing efforts to advance its pipeline and ensure compliance with stock market regulations.
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