Quoin Pharmaceuticals Announces FDA Fast Track Designation for QRX003 for the Treatment of Peeling Skin Syndrome
The FDA granted Fast Track Designation to QRX003 for the treatment of Peeling Skin Syndrome -- the first-ever Fast Track designation for any PSS therapy and the second for the asset, following the Netherton Syndrome designation granted March 11, 2026. The designation follows July 2026 clearance of the first IND ever submitted to the FDA for PSS; Quoin expects to initiate a Phase 2/3 study in the second half of 2026, enrolling up to 12 pediatric and adult patients in the U.S. and Europe, with dosing over 48 weeks, a 24-week interim review, and a 2028 approval target.
Key figures
- Drug Name
- QRX003
- Phase Of Trial
- Phase 2/3
- Dosing
- twice-daily topical application to >80% body surface area
- Indication
- Peeling Skin Syndrome
- Approval target
- 2028
- Planned enrollment
- up to 12 pediatric and adult patients (U.S. and Europe)
- Interim review week
- 24
- Study duration weeks
- 48
- Adverse events reported
- none
- Prior fast track indication
- Netherton Syndrome (granted March 11, 2026)
- Single subject treatment duration
- more than 15 months
AI analysis
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