Quoin Pharmaceuticals Ltd. (QNRX), a late-stage clinical company, provided a clinical and regulatory update following its recent Type C meeting with the U.S. Food and Drug Administration for its lead product candidate, QRX003, for the treatment of Netherton Syndrome.
In addition, QNRX is scheduled to report its fourth-quarter and full-year 2025 financial results today.
Following the Type C meeting update and with results ahead, QNRX is down 6.36% at $8.68 in the overnight market.
QRX003, Quoin's lead product, is a topical lotion developed to treat Netherton Syndrome.
Netherton Syndrome is caused by a mutation of the SPINK5 gene, which leads to severe skin barrier defects, recurring severe infections and pronounced predisposition to allergies, asthma, skin cancers and eczema.
According to the firm, the FDA acknowledged that a single Phase 3 study may be sufficient to support U.S. marketing approval of QRX003 for Netherton Syndrome, rather than the two Phase 3 studies the company had initially contemplated.
Additionally, the FDA indicated that they are open to alternative clinical trial designs, such as randomised withdrawal or randomised delayed start, for the pivotal Phase 3 study.
Also, Quoin will submit clinical data from the ongoing Phase 2 and paediatric investigator studies and plans to request a meeting to discuss this data prior to initiating the Phase 3 pivotal program for QRX003 to align with the FDA on the program's design.
Quoin also noted that it remains on track to initiate a Phase 3 study, complete patient recruitment by the end of 2026, and potentially file for NDA approval in 2027.
Quoin's Pipeline
Quoin's pipeline includes investigational candidates targeting rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, SAM Syndrome, Scleroderma, Microcystic Lymphatic Malformations, Venous Malformations, and Ichthyosis. The lead product, QRX003, is also being explored for Peeling Skin Syndrome, SAM Syndrome, and Ichthyosis.
The firm's pipeline also includes QRX008 for the treatment of Scleroderma and QRX009 for Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma, and other indications.
QNRX has traded between $5.01 and $41.80. The stock closed Wednesday's trade at $9.27, up 15.44%.
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