earnings
confidence high
sentiment positive
materiality 0.65
Quoin Q1 net loss $5M; FDA says single Phase 3 may suffice for QRX003
Quoin Pharmaceuticals, Ltd.
- Net loss $5.0M in Q1 2026 vs $3.8M in Q1 2025; cash $14M expected to fund operations into 2027.
- FDA granted Fast Track Designation for QRX003 (Netherton Syndrome); Type C meeting indicated single Phase 3 may support U.S. approval.
- Phase 3 patient recruitment on track to complete by end of 2026; potential NDA filing in 2027.
- Japan MHLW confirmed QRX003 qualifies for Orphan Drug and Fast Track review; Saudi FDA Breakthrough Medicine Designation application filed.
- QRX009 topical rapamycin platform advancing; planned IND submission for additional indication by Q3 2026.