StockWatch
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American Depositary Receipts
Business UpdateJul 30, 2026, 06:16 AM

Clinuvel Updates on Vitiligo Market, SCENESSE® Trial Progress

AI Summary

Clinuvel Pharmaceuticals provided a commercial update on the emerging vitiligo market, comparing its SCENESSE® (afamelanotide) therapy with current standard of care (NB-UVB) and developing JAK inhibitors. The company highlighted SCENESSE®'s potential as a systemic repigmentation therapy for extensive vitiligo, noting its different mechanism of action compared to immune-suppressing JAK inhibitors. Clinuvel anticipates topline results from its CUV105 study in December 2026 and plans to start the pivotal CUV107 study in November 2026, alongside ongoing commercial preparations.

Key Highlights

  • Clinuvel provided a commercial update on the vitiligo market and SCENESSE® development.
  • SCENESSE® is being developed as a systemic repigmentation therapy for extensive vitiligo.
  • Topline results for the CUV105 study are anticipated in December 2026.
  • The pivotal CUV107 study is expected to commence in November 2026.
  • Commercial preparations include reinforcing the supply chain and engaging over 100 Specialty Centers.
  • NB-UVB monotherapy provides 40-50% repigmentation after 12 months.
  • Topical ruxolitinib achieved 45-50% facial vitiligo improvement at week 24.
  • Oral JAK inhibitors showed 15.7-21.5% total body vitiligo improvement.