Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) announced that the U.S. Food and Drug Administration granted Fast Track Designation to QRX003 lotion (4%) for treating Netherton Syndrome, a rare genetic skin disorder with no approved treatments.

The designation facilitates development and expedites regulatory review of therapies addressing serious conditions with significant unmet medical need. QRX003 is currently being evaluated in two late-stage whole-body clinical trials for Netherton Syndrome patients.

"We believe that the FDA's decision to grant Fast Track Designation to QRX003 reflects the urgent unmet need faced by patients and families living with Netherton Syndrome," said Dr. Michael Myers, CEO and Co-Founder of Quoin Pharmaceuticals. "Fast Track status enables more frequent communication with the FDA and the potential for accelerated regulatory review pathways."

QRX003 previously received Orphan Drug Designation from both the FDA and European Medicines Agency for Netherton Syndrome treatment. The FDA also granted the drug Pediatric Rare Disease Designation.

Netherton Syndrome is caused by mutations in the SPINK5 gene, leading to severe skin barrier dysfunction, chronic inflammation, and heightened risk of infections and allergic complications. Patients experience widespread skin redness, scaling, and persistent itching.

The FDA's Fast Track program expedites review of drugs treating serious conditions with unmet medical need. Designated therapies may benefit from more frequent FDA interactions, rolling review eligibility, and potential qualification for Accelerated Approval and Priority Review.

Quoin Pharmaceuticals focuses on developing therapeutic products for rare and orphan diseases. The company's pipeline targets multiple rare indications including Peeling Skin Syndrome, Palmoplantar Keratoderma, and Scleroderma.