CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY; XETRA-DAX: UR9) is a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic and skin disorders. As pioneers in understanding the interaction of light and human biology, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for photoprotection and repigmentation. These patient groups range in size from 5,000 to 45 million worldwide. CLINUVEL’s lead product, SCENESSE® (afamelanotide 16mg), was approved by the European Commission in 2014 for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). In October 2019 the US FDA approved SCENESSE® (afamelanotide) to increase pain free light exposure in adult patients with a history of phototoxic reactions from EPP. More information on EPP can be found at http://www.epp.care.
Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Switzerland, the US and Singapore.
Shares on Issue
Conditional performance rights
52 week price range (27/08/20)
$12.92 – $45.88
Market cap (27/08/20)
Swiss operational office
UK operational office
Asian operational office
US operational office
Level 1 ADR
Key financial statistics FY June 2020
Net cash increase
SCENESSE® (afamelanotide 16mg implant)
First-in-class photoprotective and repigmentation drug with EMA and US FDA approvals for rare disease EPP. Phase IIb trial completed in Singapore for vitiligo.
Alpha-Melanocyte Stimulating Hormone
(alpha-MSH) analogues in early development.
PRÉNUMBRA® is a liquid (non-solid) injectable formulation of afamelanotide designed for administration by a healthcare professional and intended to provide a flexible dose of afamelanotide, a synthetic analogue of natural α-melanocyte stimulating hormone.
Dr Philippe Wolgen
Dr Karen Agersborg
Professor Jeffrey V. Rosenfeld
Dr Dennis Wright
Acting Chief Scientific Officer
CFO, Company Secretary
Last Updated: 27 August 2020