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ASHBURN, Va. - The U.S. Food and Drug Administration has granted Rare Pediatric Disease Designation for QRX003, a drug being developed by Quoin Pharmaceuticals Ltd. (NASDAQ:QNRX) to treat Netherton Syndrome, the company announced Tuesday. According to InvestingPro data, the clinical-stage pharmaceutical company, currently valued at $5 million, maintains a strong liquidity position with a current ratio of 2.57x, indicating sufficient resources to fund its development programs.
This designation follows the European Medicines Agency’s Orphan Drug Designation for the same treatment in May 2025. Netherton Syndrome is a rare genetic disorder affecting approximately 1 in 200,000 newborns worldwide, with symptoms typically appearing at birth or in early infancy. While the company’s stock has experienced significant volatility, trading between $5.01 and $54.95 over the past 52 weeks, InvestingPro analysis suggests the stock is currently undervalued.
"We are very pleased to announce the receipt of Rare Pediatric Disease Designation for QRX003 for Netherton Syndrome, a severe and underserved genetic disease," said Dr. Michael Myers, Chief Executive Officer of Quoin Pharmaceuticals.
The FDA’s Rare Pediatric Disease Designation program aims to encourage development of therapies for serious diseases primarily affecting individuals under 18 years of age. If a New Drug Application for QRX003 is approved, Quoin may be eligible to receive a Priority Review Voucher upon reauthorization of the program.
Netherton Syndrome can cause severe skin inflammation, dehydration, and increased infection risk in infants, often requiring prolonged hospitalization. The mortality rate in infancy is estimated at 10 to 20 percent.
Quoin Pharmaceuticals is currently conducting pivotal clinical studies for QRX003 and working toward submitting a New Drug Application. The company stated in its press release that it has observed promising efficacy data and a clean safety profile in studies conducted to date. While analysts don’t expect profitability this year, with projected EPS of -$18.13 for 2025, detailed financial analysis and additional insights are available in the comprehensive Pro Research Report on InvestingPro, which covers over 1,400 US stocks with expert analysis and actionable intelligence.
In other recent news, Quoin Pharmaceuticals Ltd. has received FDA clearance to initiate a pivotal clinical study for QRX003, aimed at treating Netherton Syndrome. This study will evaluate the drug’s efficacy when used with off-label systemic therapy, involving up to 15 subjects. Additionally, Quoin announced positive initial results from a clinical study for Pediatric Peeling Skin Syndrome, where QRX003 showed significant improvement in the patient’s skin condition after 12 weeks. In regulatory developments, Quoin has regained compliance with Nasdaq’s minimum bid price requirement, ensuring its continued listing on the exchange. The company achieved this by maintaining a minimum bid price of $1.00 per share for 13 consecutive business days. To further meet Nasdaq’s requirements, Quoin has adjusted the ratio of its American Depositary Shares, changing from one ADS representing one Ordinary Share to one ADS representing twenty Ordinary Shares. These developments reflect Quoin’s ongoing efforts to advance its clinical programs and maintain its market position.
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