InvestSMART

Clinuvel Pharmaceuticals Limited (ASX:CUV)

ALERT: Price-sensitive ASX Announcement for CUV
Current share price for CUV : $10.360 0.55 (5.61%)+
Announcement
Release
28 Jul 2026 8:56AM
Price at Release
$9.810
Full Release
download
Summary
Clinuvel Pharmaceuticals Limited is advancing its SCENESSE® (afamelanotide) drug in combination with narrowband UVB (NB-UVB) therapy as a treatment for vitiligo, focusing on patients with darker skin types. The CUV105 study, involving 210 patients globally, is set to deliver results by December 2026, evaluating total body and facial repigmentation efficacy. Following EMA's protocol review, the pivotal CUV107 Phase III study is slated to start in November 2026 with 300 participants. The regulatory approval for vitiligo treatment hinges on the outcomes of these studies, as SCENESSE® is currently only approved for erythropoietic protoporphyria.
Key Points
  • CUV105 study involves 210 patients globally for SCENESSE® with NB-UVB in vitiligo treatment.
  • Primary endpoint: =50% total body surface area response (T-VASI50).
  • Secondary endpoint: =75% facial repigmentation improvement (F-VASI75).
  • Topline results of CUV105 expected by December 2026.
  • CUV107 pivotal Phase III to follow with 300 patients, beginning November 2026.
  • EMA reviewed CUV107 protocol; will include darker skin types (Fitzpatrick IV-VI).
  • Positive initial clinical observations for SCENESSE® with NB-UVB.
  • Phase II CUV102 showed sustained repigmentation.
  • SCENESSE® approved for erythropoietic protoporphyria but not for vitiligo yet.
  • Future regulatory approval contingent on results of CUV105 and CUV107.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.