Quoin Pharmaceuticals receives FDA rare pediatric disease designation for QRX003

Published 25/06/2025, 14:10
Quoin Pharmaceuticals receives FDA rare pediatric disease designation for QRX003

Quoin Pharmaceuticals Ltd. (NASDAQ:QNRX) announced Tuesday that the U.S. Food and Drug Administration has granted Rare Pediatric Disease Designation to its lead asset, QRX003, for the treatment of Netherton Syndrome. The company, currently valued at $5.28 million, disclosed this development in a press release statement included in a filing with the Securities and Exchange Commission. According to InvestingPro data, analysts maintain a bullish outlook on the stock, with price targets significantly above current levels.

QRX003 is in late-stage clinical development and is intended for patients with Netherton Syndrome, a rare genetic skin disorder. The Rare Pediatric Disease Designation is part of an FDA program that recognizes drugs and biologics targeting serious or life-threatening diseases that primarily affect children. InvestingPro analysis shows the company maintains a healthy balance sheet with more cash than debt, though it’s currently not profitable.

Quoin Pharmaceuticals is incorporated in Israel and its American Depositary Shares are listed on the Nasdaq Stock Market under the symbol QNRX. The company’s principal executive offices are located in Ashburn, Virginia.

The information in this article is based on a press release statement contained in a recent SEC filing.

In other recent news, Quoin Pharmaceuticals Ltd. announced significant developments concerning its investigational drug QRX003 for Netherton Syndrome. The U.S. Food and Drug Administration has granted the drug Rare Pediatric Disease Designation, which follows a similar designation by the European Medicines Agency earlier this year. This designation could lead to a Priority Review Voucher if a New Drug Application is approved. Additionally, Quoin received FDA clearance to initiate a pivotal clinical study for QRX003, aiming to evaluate its efficacy in combination with systemic therapy. Positive initial results were also reported from an ongoing study using QRX003 for Pediatric Peeling Skin Syndrome, showing significant improvement in patients’ skin conditions. In regulatory news, Quoin Pharmaceuticals has regained compliance with Nasdaq’s minimum bid price requirement, ensuring its continued listing on the exchange. The company confirmed that its shares met the necessary criteria, closing at or above $1.00 per share for 13 consecutive business days. These developments reflect Quoin’s ongoing efforts to advance its pipeline of treatments for rare and orphan diseases.

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