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Monday, 19 September 2016

Chair’s Letter

19 September 2016   This summer our team supplied the first SCENESSE® (afamelanotide 16mg) treatment for erythropoietic protoporphyria (EPP) patients in the Netherlands and Austria. It has been a long journey and our gratitude goes to the forbearance of patients, physicians, and shareholders alike in supporting the efforts of a dedicated Clinuvel staff, who must […]

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24 August 2016   Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) is a global biopharmaceutical company focused on developing drugs for the treatment of a range of severe skin disorders. With its unique expertise in understanding the interaction of light and human skin, the Company has identified patients with a clinical need for […]

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23 August 2016   CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) wishes to advise in accordance with the terms and conditions of issue that the following unquoted conditional performance rights have lapsed and forfeited: Class Number Exercise price CUVAK Conditional Performance Rights subject to various performance milestones, issued various dates under the 2009 […]

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Sunday, 14 August 2016

CLINUVEL Newsletter – August 2016

16 August 2016   In the arduous journey from explorative concept to development to commercial availability of the novel molecular entity – SCENESSE® afamelanotide 16mg)1 – one may become engrossed in the processes leading to the desired outcome. The ultimate goal of changing people’s lives is what drives us at Clinuvel and our team is […]

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Tuesday, 09 August 2016

Notice of Initial Substantial Holder

10 August 2016 Enclosed are the details of a notice of initial substantial holder. Download PDF for more

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Wednesday, 03 August 2016

Appendix 3Y

03 August 2016   We (the entity) give ASX the following information under listing rule 3.19A.2 and as agent for the director for the purposes of section 205G of the Corporations Act.    Download PDF for more

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Tuesday, 02 August 2016

Appendix 3B

02 August 2016   New issue announcement, application for quotation of additional securities and agreement   Download PDF for more

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02 August 2016   CLINUVEL prepares New Drug Application (NDA) for the treatment of erythropoietic protoporphyria (EPP) Executive summary: FDA requirement for combination therapy model replicating clinical studies protocol in vitiligo fulfilled Safety of the combination therapy confirms observations in clinical trials CUV102 and CUV103 CLINUVEL will request a guidance meeting with the FDA to […]

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Thursday, 28 July 2016

Appendix 4C – Q4 FY16

28 July 2016   Enclosed is a copy of the quarterly report for the period ending 30 June 2016   Download PDF for more

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17 July 2016   Clinuvel prepares New Drug Application (NDA) for the treatment of erythropoietic protoporphyria (EPP) Executive summary: FDA concludes initial review of datasets on SCENESSE® in EPP FDA deems datasets satisfactory for submission of New Drug Application Pre-NDA meeting with FDA to be scheduled to discuss timelines and procedure Clinuvel will request rolling […]

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05 July 2016   Executive summary: FDA awards Fast Track Designation¹ to expedite review of SCENESSE® in EPP NDA filing allowed on a rolling basis FDA hosting a Scientific Workshop² on EPP to learn more about disease and drug treatment Clinuvel Pharmaceuticals [ASX: CUV; Nasdaq International Designation ADR: CLVLY; Xetra-DAX: UR9] today announced that the […]

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20 June 2016   First commercial delivery, SCENESSE® approved as standard of care in the Netherlands. CLINUVEL Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that its drug SCENESSE® (afamelanotide 16mg) has been launched in Europe, with the first commercial delivery of the product under European marketing authorisation. Patients with the rare genetic disorder […]

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 31 May 2016   CLINUVEL Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced the inclusion of its Sponsored Level 1 American Depository Receipt (ADR) program in Nasdaq’s International Designation, a new visibility offering available to non-US companies. CLINUVEL is the first life science company to be selected for this initiative, first launched by […]

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Tuesday, 17 May 2016

SCENESSE® treatment in Europe

17 May 2016   German Porphyria Expert Centres to start distribution of SCENESSE® (afamelanotide 16mg) Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced an update on the company’s post-authorisation distribution of SCENESSE® (afamelanotide 16mg) across Europe for adult patients with the rare disorder erythropoietic protoporphyria (EPP).   Download PDF for more

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Friday, 29 April 2016

Appendix 4C – Q3 FY16

29 April 2016   Enclosed is a copy of the quarterly report for the period ending 31 March 2016.   Download PDF for more

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Thursday, 16 January 2020

CLINUVEL Newsletter

Dear shareholders, friendsOn behalf of the CLINUVEL Board, I wish you all a good new year in the hope that it confers you with good health and prosperity, in that particular sequence. We thank and …

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Thursday, 05 December 2019

Appendix 3B

 New issue announcement, application for quotation of additional securities and agreement. 

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Monday, 02 December 2019

CEO Letter

Dear shareholders, On 8 October 2019, CLINUVEL obtained its first and historic US Food and Drug Administration (FDA) approval, some 39 years since the afamelanotide technology was first discovered in a university laboratory. On this day …

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Dearest Shareholders, As the incoming Chair of the Company, in short letters I will try to provide you with updates and inform you about our business.[...]

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 CLINUVEL PHARMACEUTICALS LTD today announced that Mr Stan McLiesh will retire from his role as Non-Executive Director and Chair of the Board on 30 November 2019. Non-Executive Director Mr Willem Blijdorp has been elected Chair …

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Thursday, 17 October 2019

CLINUVEL Newsletter

  In this News Communiqué VII, we pause to reflect on the outstanding US regulatory outcome and look back one last time at all the events which led to the long-desired outcome on 8 October, the …

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Tuesday, 15 October 2019

Chair Letter to Shareholders

  Dear All, In my career in life sciences, I have served on public Boards, was part of the management team that led CSL to its position and oversaw several executive transitions in our beloved Company, first …

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Tuesday, 20 August 2019

CLINUVEL Newsletter - August 2019

  Dear patients, shareholders, friends, In this News Communiqué VI for the year we report further on CLINUVEL’s regulatory progress in the US and the latest quarterly results for the period ending 30 June 2019. [...]

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Thursday, 11 July 2019

CLINUVEL Newsletter - July 2019

  In this Communiqué we turn our attention to the most recent news communicated to the Company on 31 May by the US Food and Drug Administration (FDA): an extension of the scientific review time for …

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Thursday, 02 May 2019

CLINUVEL Newsletter

02 May 2019  Dear patients, shareholders, friends,In this Communiqué we concentrate on CLINUVEL’s programs and US market access for SCENESSE®.As the European season unfolds, we report on the back of quarterly financials (released 30 April) …

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