Clinuvel Pharmaceuticals Limited

We are a global biopharmaceutical company committed to developing drugs for the treatment of a range of severe skin disorders.

Our website has been developed to help share our expertise on the interaction of light and human skin as well as provide a thorough overview of our global drug development programs.

CLINUVEL’s lead compound, SCENESSE® (afamelanotide 16mg), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe.

In December 2014 the European Commission granted SCENESSE® marketing authorisation under exceptional circumstances for the prevention of phototoxicity in adult patients with EPP.

In October 2019, the US FDA granted CLINUVEL marketing approval for SCENESSE® (afamelanotide 16mg) to increase pain free light exposure in adult patients with a history of phototoxic reactions from EPP.

Further trials of SCENESSE® are underway in the pigmentary disorder vitiligo

ASX Code
CUV

Sector
Pharmaceuticals- Biotechnology & Life Sciences

Website
https://www.clinuvel.com/

Spotlight Videos

Stocks of the Hour: Clinuvel Pharmaceuticals, Mt Malcolm Mines, Auric Mining

July 5, 2024 - by Abbey Phillipps

A snapshot of the stocks on the move, featuring Clinuvel Pharmaceuticals (ASX:CUV), Mt Malcolm Mines (ASX:M2M) and Auric Mining (ASX:AWJ).

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News

Injecting hope: Clinuvel eyes higher SCENESSE usage in Europe

November 20, 2024 - by Finance News Network

Clinuvel Pharmaceuticals (ASX:CUV) has entered discussions with the European Medicines Agency to increase the recommended maximum annual dosage of its flagship SCENESSE drug.

Clinuvel narrows focus to prioritise key programs

November 18, 2024 - by Finance News Network

Melbourne-based Clinuvel Pharmaceuticals (ASX:CUV) has announced a strategic shift to focus on three core clinical programs while pausing others.

The Business Models Holding Up In The Rout

April 1, 2020 - by Tim Boreham

Beyond the dismal parade of ASX-listed victims ensuing from the corona crisis, a low-profile cluster of stocks is benefiting from the mayhem.

Clinuvel Pharmaceuticals – Minimal Concerns Over FDA Delay

June 11, 2019 - by Tim McGowen

Investors were quick to drop Clinuvel shares after an update on the Prescription Drug User Fee Act (PDUFA) goal date for its SCENESSE product. However, analysts at Moelis note that while any delay around FDA approval is disappointing, it's likely only a timing issue.