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  This Explanatory Memorandum has been prepared for the Shareholders of the CLINUVEL PHARMACEUTICALS LIMITED in connection with the business to be conducted at the Annual General Meeting of Shareholders of the Company which will be held at The Events Centre at Collins Square, Tower 2, Level 5, 727 Collins Street, Melbourne, VIC 3008, Australia. […]

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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 Food and Drug Administration’s (FDA’s) approval of SCENESSE® (afamelanotide 16mg). […] Download PDF  

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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 at Epitan and last, but not least, at CLINUVEL. […] Download PDF

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Thursday, 10 October 2019

Audio Transcript Investor Teleconference

  An audio transcript of the investor teleconference held yesterday can be found on the CLINUVEL PHARMACEUTICALS LTD website at http://www.clinuvel.com/IRteleconf20191009. Download PDF

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  It is a privilege for CLINUVEL PHARMACEUTICALS LTD to announce the US Food & Drug Administration (FDA) has granted marketing approval to use SCENESSE® (afamelanotide 16mg) for the treatment of EPP patients in the United States. […] Download PDF

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Tuesday, 08 October 2019

Trading Halt

  The securities of Clinuvel Pharmaceuticals Limited (CUV) will be placed in trading halt at the request of CUV, pending it releasing an announcement. Unless ASX decides otherwise, the securities will remain in trading halt until the earlier of the commencement of normal trading on Friday, 11 October 2019. […] Download PDF

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  CLINUVEL PHARMACEUTICALS LTD today announced that it has renewed the Employment Agreement with life science executive and CLINUVEL Managing Director Dr Philippe Wolgen for a term of three years ending 1 July 2022. […] Download PDF

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Wednesday, 02 October 2019

FDA Clarifies SCENESSE® PDUFA Date

  CLINUVEL PHARMACEUTICALS LTD today announced that the US Food and Drug Administration (FDA) has notified the company that the Prescription Drug User Fee Act (PDUFA) goal date for review of the submission of the SCENESSE® (afamelanotide 16mg) scientific dossier had been miscommunicated by the Agency and now has been confirmed for 8 October 2019, […]

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Monday, 30 September 2019

CLINUVEL Confirms AGM Date

  CLINUVEL PHARMACEUTICALS LTD today announced it will hold its 2019 Annual General Meeting of shareholders on Wednesday 20 November 2019 at 10.00 am AEDT. […] Download PDF

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Wednesday, 25 September 2019

Appendix 3X

  Initial Director’s Interest Notice Download PDF

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Monday, 23 September 2019

CLINUVEL Appoints New Director

  CLINUVEL PHARMACEUTICALS LTD today announced the appointment of Susan (Sue) Smith as a Non-Executive Director of the Group’s Board of Directors. The appointment is effective today. […] Download PDF

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Tuesday, 10 September 2019

SCENESSE® presented at ICPP in Milan

  CLINUVEL PHARMACEUTICALS LTD today announced that safety and effectiveness data from the treatment of erythropoietic protoporphyria (EPP) patients with SCENESSE® (afamelanotide 16mg), will be presented this week at the International Congress on Porphyrins and Porphyrias (ICPP) in Milan, Italy. […] Download PDF

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Tuesday, 03 September 2019

Appendix 3Y

  Change of Director’s Interest Notice Appendix 3Y    

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  Download Notification of Dividend/Distribution

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Wednesday, 28 August 2019

CLINUVEL Clarifies ex-Dividend Date

  In relation to the dividend announcement earlier today, CLINUVEL PHARMACEUTICALS LTD clarifies the ex-dividend date is to be 04 September 2019. Download PDF

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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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Wednesday, 24 April 2019

Chair Letter to Shareholders

24 April 2019   Dear All,On a continent where very few biotechnology and pharmaceutical companies have ever succeeded in taking a first-in-class and first-in-line therapy from concept to commercialisation, CLINUVEL has all the makings of becoming …

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