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Clinuvel Pharmaceuticals Limited (ASX:CUV)

ALERT: Price-sensitive ASX Announcement for CUV
Current share price for CUV : $9.060 -1.21 (-11.78%)+
Release
13 Jul 2026 8:34AM
Price at Release
$10.270
Full Release
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Summary
Clinuvel Pharmaceuticals Limited announced that its novel drug SCENESSE® (afamelanotide) has been granted a Notice of Compliance by Health Canada for the treatment of erythropoietic protoporphyria (EPP), a rare metabolic disorder. The approval acknowledges the compliance of SCENESSE® with Canadian regulations and allows Clinuvel to market the drug in Canada. SCENESSE® has shown a consistent safety profile and clinical benefits in preventing phototoxicity in EPP patients. This approval in Canada follows previous authorizations in Europe, the USA, and Australia. Clinuvel has established a network of Specialty Centers in North America, with several centers in Canada already trained and accredited to administer SCENESSE®.
Key Points
  • SCENESSE® approved by Health Canada for EPP.
  • The drug prevents phototoxicity in EPP patients.
  • SCENESSE® has a proven long-term safety profile.
  • Approval follows previous authorizations in Europe, USA, and Australia.
  • Clinuvel has established Specialty Centers across North America.
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.