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21 December 2017 CLINUVEL PHARMACEUTICALS LTD today announced that the first draft assessment from England’s National Institute for Health and Care Excellence (NICE) has been published, with SCENESSE® (afamelanotide 16mg) not recommended for reimbursement for the ultra-orphan disorder erythropoietic protoporphyria (EPP), subject to NICE’s final recommendation expected in May 2018. SCENESSE® is the only approved […]

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Thursday, 07 December 2017

CLINUVEL Newsletter – December 2017

07 December 2017   The CLINUVEL team is looking with much optimism and energy to the start of 2018. I believe the year ahead is one where the Company will make great strides on various fronts: research, product development, distribution, and restructuring of the Group of companies. We all eagerly await the day our teams […]

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05 December 2017   CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY) wishes to advise in accordance with the terms and conditions of issue that the unquoted performance rights enclosed have lapsed and forfeited.   Download PDF for more

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05 December 2017   We (the entity) give ASX the following information under listing rule 3.19A.3 and as agent for the director for the purposes of section 205G of the Corporations Act.   Download PDF for more

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Monday, 27 November 2017

Results of Meeting

27  November 2017 In accordance with Listing Rule 3.13.2 and section 251AA of the Corporations Act, we advise details of the resolutions and the proxies received in respect of each resolution are set out in the attached proxy summary. Download PDF for more

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Monday, 27 November 2017

Managing Director’s AGM Presentation

27 November 2017   Today’s discussion outlines the CLINUVEL Board’s objectives to lead the growth of the Group by 2020. The emphasis today is on the strategic direction of the Group towards growth by 2020. Audiences unfamiliar with CLINUVEL are encouraged to review the website at www.clinuvel.com. Three elements have dictated CLINUVEL’s Board strategic considerations. […]

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28 November 2017   Coming from the background of an ethical pharmaceutical company I had some misgivings 15 years ago of joining the board of a company with a ‘tanning’ drug. Here we are today, a genuine biopharmaceutical company having posted revenues of AUD$17.3m on a single drug used to treat an unusual orphan disorder. […]

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Tuesday, 07 November 2017

Response to ASX Price Query

07 November 2018   Enclosed is the response of CLINUVEL PHARMACEUTICALS LTD in regards to a price query lodged by the ASX.   Download PDF for more

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Sunday, 29 October 2017

Appendix 4C

29 October 2017   CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY), a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe and therapeutically unmet genetic disorders today announced its Appendix 4C – Quarterly Cashflow report for the period ended 30 September 2017.   […]

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26 October 2017   This Explanatory Memorandum has been prepared for the Shareholders of the CLINUVEL PHARMACEUTICALS LIMITED ACN 089 644 119 in connection with the business to be conducted at the Annual General Meeting of Shareholders of the Company.   Download PDF for more

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Thursday, 26 October 2017

Appendix 4G

26 October 2017   This statement reports on the main corporate governance practices of the Company as at 27 October 2017 and it has been approved by theBoard of the Company on 12 July 2017. This statement is organised under headings based on the Australian Securities Exchange CorporateGovernance Council’s (ASXCGC) Corporate Governance Principles and Recommendations, […]

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Monday, 16 October 2017

CLINUVEL Newsletter – October 2017

16 October 2017   I am addressing you during quite a turbulent period, when our teams are preparing various dossiers to meet regulatory obligations in Europe and the US. As recently shared through the ASX, we are inching towards the complete new drug application (NDA) submission and are increasing the data package with European data […]

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Monday, 09 October 2017

CLINUVEL CONFIRMS AGM DATE

10 October 2017   CLINUVEL PHARMACEUTICALS LTD  today announced it will hold its 2017 Annual General Meeting of shareholders on Tuesday 28 November 2017 at 10.00am AEDT at Arnold Bloch Leibler, Level 21, 333 Collins Street, Melbourne, Victoria, Australia 3000. A formal Notice of Meeting and the Company’s Annual Report will be lodged with the […]

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Wednesday, 04 October 2017

ELIE ISHAG TO RETIRE FROM CLINUVEL BOARD

04 October 2017   CLINUVEL PHARMACEUTICALS LTD today announced that Mr Elie Ishag has advised that he will not stand for re-election as Non-Executive Director of CLINUVEL at the Company’s 2017 Annual General Meeting. He will continue to serve on the Board of CLINUVEL until the date of the Meeting.   Download PDF for more

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19 September 2017   CLINUVEL PHARMACEUTICALS LTD  today announced an update on its submission of the New Drug Application (NDA) for CLINUVEL’s drug SCENESSE® (afamelanotide 16 mg) to the US Food and Drug Administration (FDA). EUROPEAN POST-MARKETING SAFETY DATA TO BE SUBMITTED AS PART OF NEW DRUG APPLICATION (NDA), EXPECTED IN DECEMBER 2017 NO RISK EVALUATION […]

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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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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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