regulatory
confidence high
sentiment positive
materiality 0.60
FDA grants Fast Track to Quoin's QRX003 for Peeling Skin Syndrome
Quoin Pharmaceuticals, Ltd.
- FDA granted Fast Track Designation to QRX003 for Peeling Skin Syndrome (PSS) on Sept 22, 2026.
- First-ever Fast Track for a PSS therapy; second Fast Track for QRX003 (prior: Netherton Syndrome).
- Follows July 2026 FDA clearance of first-ever IND for PSS; Phase 2/3 study planned 2H 2026.
- Phase 2/3 to enroll up to 12 pediatric/adult patients; targeting 2028 approval; no approved PSS treatment.