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Thursday, 31 October 2019

Appendix 4C

CLINUVEL PHARMACEUTICALS LTD, a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic and skin disorders, today announced its Appendix 4C – Quarterly Cashflow Report for the period 01 July to 30 September 2019. Download PDF

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CLINUVEL PHARMACEUTICALS LTD today announced that the Australian Therapeutic Goods Administration (TGA) has granted SCENESSE® (afamelanotide 16 mg) the right to be filed under the priority registration process. This establishes a target scientific evaluation timeframe of 150 working days, calculated from the first day the scientific dossier is accepted. SCENESSE® will be lodged for the […]

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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.[…] Download PDF

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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 and will take on the role on 30 November 2019. […] Download PDF

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  CLINUVEL PHARMACEUTICALS Corporate Governance Statement has been updated and is available to download. Download PDF  

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Friday, 18 October 2019

Annual Report to shareholders

  CLINUVEL’s Annual Report for the year ended 30 June 2019. Download 2019 Annual Report

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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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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 …

Download PDF
 
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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Wednesday, 20 March 2019

CLINUVEL Newsletter – March 2019

20 March 2019  Dear patients, shareholders, friends,In the third Communiqué we are reviewing our EU operations, the impact of Brexit and looking at the year ahead. FDA REVIEWAt the time of print CLINUVEL will find itself …

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Tuesday, 12 February 2019

CLINUVEL Vitiligo Communiqué II

12 February 2019   In the second Communiqué we look closer at the role of narrowband UVB (NB-UVB) as the only standard of care at present in vitiligo, both the segmental and generalised form of the disease. …

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