Clinuvel Pharmaceuticals (ASX: CUV) is an Australian biopharmaceutical company developing a photoprotective pharmaceutical under the generic name afamelanotide. The company's focus is to gain market approval for afamelanotide to manage the symptoms of severe sufferers of UV and light related skin disorders.
Clinuvel Pharmaceuticals (ASX: CUV) has received a price and volume query from the ASX after its shares jumped to A$1.92 yesterday, 12 January, up from $1.58 at the close of trading on Friday 6 January.
The company responded to the ASX saying it is not aware of any material information that has not been disclosed to the market, which may explain the sudden investor interest.
However, Clinuvel did refer to its recent announcements in November and December of positive results from its Phase II U.S. clinical trial and its pivotal Phase III European clinical trial.
Both studies related to the company’s lead indication (erythropoietic protoporphyria) for its first-in-class drug SCENESSE® (afamelanotide).
SCENESSE® is being developed as a treatment for people suffering from a loss of melanin production resulting in white or off-white depigmented skin lesions on different parts of the body.
Clinuvel is also finalising a Marketing Authorisation Application for SCENESSE® for submission to the European Medicines Agency within the next few weeks.
An approved MAA would allow the company to market SCENESSE® across the European Union.