Quoin Pharmaceuticals Secures FDA Conditional Approval of QYLEKI™ Brand Name for QRX003

Another step in preparing QRX003 for potential commercialization

Quoin Pharmaceuticals (NASDAQ: QNRX) has received FDA conditional approval of QYLEKI™ as the proposed brand name for QRX003, its investigational topical treatment for Netherton Syndrome.

The brand-name approval is part of Quoin’s commercial preparation for QRX003, and it comes as the program continues to build regulatory and clinical momentum. The program has received Orphan Drug Designation in the United States, the European Union, and Japan, along with Fast Track and Rare Pediatric Disease Designations from the FDA. Quoin has stated that final approval of the QYLEKI name will be sought as part of a future New Drug Application.

The company expects to initiate its pivotal Phase 3 study in the second half of 2026, with a potential NDA filing in 2027. The naming decision follows a positive clinical update released on June 16 from Quoin’s ongoing pediatric Netherton Syndrome Compassionate Use Program.

If approved, QRX003 would become the first treatment approved for Netherton Syndrome.

Netherton Syndrome is a rare genetic skin disease caused by mutations in the SPINK5 gene. It has no approved treatment today, leaving patients and families to manage a lifelong condition with supportive and off-label care alone. For that community, an approval would not be incremental. It would be a first.

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