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Clinuvel Pharmaceuticals Limited (ASX:CUV)

ALERT: Price-sensitive ASX Announcement for CUV
Current share price for CUV : $10.700 1.66 (18.36%)+
Announcement
Release
27 Apr 2026 8:42AM
Price at Release
$9.040
Full Release
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Summary
Clinuvel Pharmaceuticals Limited has announced that the U.S. FDA has reviewed and subsequently removed the requirement for a post-authorization phase I QT study regarding the cardiac repolarization of SCENESSE® (afamelanotide). This decision follows extensive long-term safety data showing the drug’s stability, negating the need for such a study. SCENESSE® is indicated for erythropoietic protoporphyria (EPP), being the only FDA-approved treatment for this condition, with over 20,000 doses administered worldwide. The relaxation of this postmarketing requirement demonstrates the FDA's confidence in the drug's safety profile, supported by continuous safety data submissions from Clinuvel.
Key Points
  • FDA removes requirement for cardiac repolarization QT study for SCENESSE®.
  • Extensive long-term safety data contributed to FDA's decision.
  • SCENESSE® is the only FDA-approved treatment for erythropoietic protoporphyria (EPP).
  • More than 20,000 doses of SCENESSE® have been administered worldwide.
  • Clinuvel's data submission since 2019 led to relaxed postmarketing requirements.
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.