QRX003 - (CL-QRX003-002)

June 23, 2026: Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) announced the FDA has conditionally accepted QYLEKI™ as the proposed proprietary (brand) name for QRX003, its investigational topical lotion (4%) for Netherton Syndrome. The company said final brand-name approval would occur upon FDA marketing approval, and that the proprietary name review request will be included in a future New Drug Application (NDA).

Regulatory designations cited for QRX003 include Orphan Drug Designation in the U.S., EU, and Japan, plus FDA Fast Track and Rare Pediatric Disease Designations.

Clinical/regulatory timeline: QRX003 is being evaluated in Phase 2 whole-body trials in Netherton Syndrome. Quoin expects to initiate a pivotal Phase 3 study in the second half of 2026 and anticipates a potential NDA filing in 2027. The release also references a “positive clinical update” from an ongoing pediatric compassionate use program issued on June 16 (no specific data provided here).