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Clinuvel Pharmaceuticals Limited (ASX:CUV)

ALERT: Price-sensitive ASX Announcement for CUV
Current share price for CUV : $10.240 1.43 (16.23%)+
Announcement
Release
24 Apr 2026 8:56AM
Price at Release
$8.810
Full Release
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Summary
Clinuvel Pharmaceuticals Limited has received final scientific advice from the European Medicines Agency (EMA) for their pivotal Phase III study of SCENESSE® as a systemic treatment for vitiligo. The EMA has emphasized a 'totality of evidence' approach for evaluating the efficacy of SCENESSE®, with photographic evidence and validated disease assessment tools being integral to the study's design. The study, CUV107, will compare SCENESSE® in combination with narrowband UVB (NB-UVB) phototherapy against NB-UVB alone and is set to begin in the second half of 2026 with 300 participants. The EMA's guidance reflects a nuanced understanding of the visibility of vitiligo in darker skin types, recommending that these patients receive systemic treatment first. This study marks a significant advancement in Clinuvel's efforts to address unmet needs in vitiligo treatment, particularly for patients with extensive depigmentation.
Key Points
  • Final EMA scientific advice received for Phase III vitiligo study
  • EMA emphasizes 'totality of evidence' approach
  • SCENESSE® to be evaluated with NB-UVB phototherapy
  • Study CUV107 to involve 300 participants
  • Focus on patients with darker skin types for systemic treatment
  • Commencement of study planned for 2H 2026
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.