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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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CLINUVEL PHARMACEUTICALS LTD wishes to advise in accordance with the terms and conditions of issue that the following unquoted performance rights have lapsed and forfeited: Class  Number  Exercise  price CUVAK Conditional Performance Rights subject to various performance milestones, issued various dates 40,000 $Nil Consequently, there are now 1,666,460 unlisted conditional performance rights on issue. Download […]

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Thursday, 05 December 2019

Changes of Director’s Interest Notice

  Appendix 3Y Change of Director’s Interest Notice   Download PDF

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Thursday, 05 December 2019

Appendix 3B

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

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Thursday, 05 December 2019

Changes in Composition to Committeess

  CLINUVEL PHARMACEUTICALS LTD today announced changes to the composition of its Audit & Risk Committee and to its Remuneration Committee. Consequent to his retirement from the Board of Directors, Stan McLiesh will be replaced by Jeffrey Rosenfeld on the Audit & Risk Committee as a voting member. Sue Smith and Karen Agersborg will join […]

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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 the intraday share price went up briefly to A$45.88, valuing the Company at A$2.2B; we have seen sell offs […]

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Tuesday, 26 November 2019

Appendix 3X

Initial Director’s Interest Notice. Download PDF

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Tuesday, 26 November 2019

CLINUVEL Appoints Non-Executive Director

CLINUVEL PHARMACEUTICALS LTD today announced the appointment of Professor Jeffrey Rosenfeld as a Non-Executive member of the Group’s Board of Directors. Download PDF

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Wednesday, 29 January 2020

CLINUVEL Kommuniqué I

Sehr geehrte Aktionärinnen und Aktionäre, liebe FreundeIm 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, …

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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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