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Thursday, 12 March 2020

Chair Letter to Shareholders

Fellow shareholders, Let me start a first welcome letter by wishing you a successful and great year ahead without health issues, pertinent at the time that Corona virus is taking over the world news. Since appointed in my position I have taken on the task to oversee our Company, one with immense potential. The first […]

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CLINUVEL PHARMACEUTICALS LTD [ASX:CUV; XETRA-DAX: UR9; Nasdaq International Designation: CLVLY] today received confirmation that the US Food and Drug Administration (FDA) has designated 29 April to discuss and agree the North American development program for SCENESSE® (afamelanotide 16mg) for the pigment loss disorder vitiligo.1 PROPOSED STUDIES CUV104 AND CUV105 IN NORTH AMERICA   The proposed […]

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CLINUVEL PHARMACEUTICALS LTD today communicated in response to a number of public queries that neither the drug substance nor the excipients of SCENESSE® (afamelanotide 16mg) are affected by the coronavirus.1 The coronavirus (COVID-19) is a class 1 viral fusion protein and is not affecting the supply chain or manufacturing of SCENESSE®. THE CORONAVIRUS DISEASE (COVID-19) […]

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Thursday, 27 February 2020

Corporate Presentation Half Year Results

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Wednesday, 26 February 2020

Appendix 4D Half Yearly Report

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 financial result for the six months ended 31 December 2019. All figures are rounded and reported in Australian dollars. FINANCIAL RESULT CLINUVEL achieved positive results in the half […]

Company Announcement, 10 February 2020. CLINUVEL PHARMACEUTICALS LTD announced it has requested a Type C Guidance meeting with the FDA to seek agreement on the design of a multicentre Phase IIb vitiligo clinical study (CUV104) and the data package necessary to support a supplemental New Drug Application (sNDA) filing for CLINUVEL’s drug SCENESSE® in vitiligo.

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Refer Company Announcement, 24 February 2020. CLINUVEL PHARMACEUTICALS LTD announced it is expanding its Singapore laboratories with the support of a grant from the Singapore Economic Development Board.

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Tuesday, 25 February 2020

Appendix 3B and Appendix 3Y Withdrawn

Melbourne, Australia 25 February 2020   CLINUVEL PHARMACEUTICALS LTD (“Company”) withdraws the Appendix 3B (“Appendix 3B”) and Change of Director’s Interest Notice (“Appendix 3Y”) filed by the Company on 5 December 2019. The Appendix 3B and Appendix 3Y relate to the proposed grant of 1,513,750 unlisted performance rights to the CEO (the “Unlisted Performance Rights”) […]

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Monday, 24 February 2020

CLINUVEL Expands Singapore Laboratories

CLINUVEL PHARMACEUTICALS LTD today announced that it is investing in the further expansion of its facilities in Singapore with new state of the art and expanded laboratories to open 1 July 2020. The research and development capacity of its wholly owned subsidiary, VALLAURIX PTE LTD, will be expanded through both a new biological and analytical […]

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CLINUVEL requests Type C Guidance meeting to progress the clinical program in vitiligo CLINUVEL PHARMACEUTICALS LTD today announced it has requested a Type C Guidance meeting with the US Food and Drug Administration (FDA) to seek agreement on the design of a multicentre Phase IIb vitiligo clinical study (CUV104) and the data package necessary to […]

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EXECUTIVE SUMMARY SCENESSE® (afamelanotide 16mg) technology review starts in Australia for rare disease EPP Priority Review aims at a technology review timeframe of 150 working days Advisory Committee on Medicines may be required during the review of SCENESSE®[…] Download PDF  

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Friday, 31 January 2020

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 October to 31 December 2019. All figures are rounded and reported in Australian dollars[…]  

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Wednesday, 29 January 2020

CLINUVEL Kommuniqué I

Sehr geehrte Aktionärinnen und Aktionäre, liebe Freunde Im Namen des CLINUVEL-Ausschusses wünsche ich Ihnen allen ein gutes neues Jahr in der Hoffnung, dass es Ihnen Gesundheit und Wohlstand verleiht. Wir bedanken uns vielmals bei Stan McLiesh, der am 30. November 2019 nach 17 Dienstjahren in den Ruhestand getreten ist. Wir begrüßen Willem Blijdorp als neuen […]

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Thursday, 16 January 2020

CLINUVEL Newsletter

Dear shareholders, friends On 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 owe much to Stan McLiesh who retired on November 30 2019 after 17 years of service, we welcome Willem […]

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CLINUVEL initiates the registration process under priority review for its new pharmaceutical drug.   CLINUVEL PHARMACEUTICALS LTD today announced that it has submitted an application to the Australian Therapeutic Goods Administration (TGA) for its drug SCENESSE® (afamelanotide 16mg) to be registered in the Australian Register of Therapeutic Goods (ARTG). If registered, SCENESSE® would be made […]

www.clinuvel.com.

 

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  Form 604 – Notice of change of interests of substantial holder is available to download.

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Monday, 09 December 2019

Change of Director’s Interest Notice

Appendix 3Y – Change of Director’s Interest Notice, is available to download.

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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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