News & Events zu Quoin Pharmaceuticals Ltd (QNRX)QNRXQuoin Pharmaceuticals Ltd

Quoin Pharmaceuticals Files $150M Mixed Securities Shelf

Quoin Pharmaceuticals files $150M mixed securities shelf

Quoin Pharmaceuticals QRX003 Granted Orphan Drug Designation in Europe

Quoin Pharmaceuticals announces that its lead product candidate QRX003 has been granted Orphan Drug Designation in Europe by the European Medicines Agency, or EMA, for the treatment of Peeling Skin Syndrome. Orphan Drug Designation in Europe affords the Company incentive benefits including scientific advice on study protocols, various fee reductions and access to EU grants. If approved for marketing by the EMA, QRX003 will be granted 10 years of market exclusivity in Europe with respect to similar medicines for the treatment of Peeling Skin Syndrome. QRX003 is also currently being evaluated in late-stage clinical trials for Netherton Syndrome, a severe and devastating, life-altering rare disease for which there are currently no approved therapies.

Quoin Pharmaceuticals Receives FDA Fast Track Designation for QRX003

Quoin Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has granted Fast Track Designation, FTD, to QRX003 for the treatment of Peeling Skin Syndrome, PSS. QRX003 is an investigational topical serine protease inhibitor lotion. "This is an important regulatory milestone for QRX003 and for a community that today has no approved treatment," said Dr. Michael Myers, CEO and Co-Founder of Quoin Pharmaceuticals. "Quoin submitted the first IND ever filed with the FDA for Peeling Skin Syndrome, that IND was cleared in July, and QRX003 has now been granted Fast Track Designation for the disease. We expect to initiate our Phase 2/3 study in the second half of 2026, and we believe Fast Track status will allow us to work closely with the agency as we advance the first company-sponsored clinical study in this disease."