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CLINUVEL's company releases, including archives.

Friday, 05 February 2010 11:00

Appendix 4D - Half Yearly Report

Appendix 4D - Half Yearly Report
Erythropoietic protoporphyria (EPP) is the lead indication for afamelanotide’s final registration dossier Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) has received positive scientific advice from the European Medicines Agency (EMA) - as part of its continuing dialogue with regulatory agencies - relevant to its application for Marketing Authorisation (MAA) for EPP this year. Following this advice Clinuvel will focus resources on the final development of afamelanotide for EPP, actinic keratosis (AK, precursor to skin cancer) and polymorphic light eruption (PLE). EMA’s Committee for Human Medicinal Products (CHMP) considered Clinuvel’s existing preclinical package, accompanied by ongoing studies, adequate to…
A global academic and clinical forum to capture the growing interest in UV radiation and skin damage Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it had hosted its second Annual Scientific & Clinical Excellence Meeting (ASCEM II) in Switzerland. In light of the progress made in afamelanotide’s clinical development, more scientific interest is being shown from the medical community worldwide. Clinuvel’s objective for this meeting was to integrate basic molecular science, clinical care and medicinal photoprotection. The ASCEM was held on 21-22 February and was led by seven of the world’s foremost experts on molecular…
Phase II trial of novel drug in erythropoietic protoporphyria (EPP) to commence immediately Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that the US Food and Drug Administration (FDA) has agreed for Clinuvel to proceed under its current Investigational New Drug (IND) to conduct a Phase II clinical trial (CUV030) to evaluate afamelanotide as a first-in-class photoprotective drug in patients diagnosed with erythropoietic protoporphyria (EPP). This outcome is a breakthrough in Clinuvel’s global clinical program and will be the first therapeutic clinical trial of afamelanotide in the US. Afamelanotide was granted orphan drug designations (ODD) for EPP…
Clinuvel’s afamelanotide to be tested for absolute light intolerance in the United States A novel Australian drug to protect patients who are intolerant of light and sunlight will begin trials in the US next month. The US Food and Drug Administration (FDA) has given clearance to Melbourne’s Clinuvel Pharmaceuticals to commence a Phase II study (CUV030) of its drug, afamelanotide, in up to 60 patients diagnosed with the rare light intolerance erythropoietic protoporphyria (EPP). The six month study, to be conducted in medical centres in Alabama, California, New York, North Carolina, Texas and Utah, is the first therapeutic trial of…
Tuesday, 30 March 2010 10:00

Corporate Presentation - 30 March 2010

Corporate Presentation - 30 March 2010
Friday, 09 April 2010 09:00

Lapse of Unlisted Share Options

Lapse of Unlisted Share Options
Wednesday, 07 February 2007 11:00

Appendix 3X Ms Brenda Shanahan

Appendix 3X Ms Brenda Shanahan
Tuesday, 06 February 2007 11:00

New Non-Executive Director

Clinuvel Pharmaceuticals Limited (ASX:CUV) is pleased to announce that Ms Brenda Shanahan has been appointed to the Clinuvel Board of Directors as a non-executive Director. With over 20 years of experience in Australian and overseas economies and share markets, Ms Shanahan brings considerable financial and business expertise to Clinuvel. Ms Shanahan is well known in the business and financial community; her insights willadd significant value to the current Board and the company. Ms Shanahan is currently Chair of both St Vincent’s Health and St Vincent’s Medical Research Institute in Melbourne. She is a nonexecutive Director of JM Financial Group Ltd…
Wednesday, 31 January 2007 11:00

Open Briefing Clinuvel Phase III PLE Trials

Open Briefing Clinuvel Phase III PLE Trials

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