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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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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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Thursday, 21 May 2020

Kommuniqué III

Liebe Aktionäre, Freunde,Die außergewöhnlichen Zeiten, in denen wir leben, haben alle Kontinente beeinflusst. Jedes verlorene Leben war eins zu viel. Ich kann unseren italienischen medizinischen Kollegen, Patienten und Familien, die mit der Tragödie kämpfen, nicht …

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Tuesday, 19 May 2020

CLINUVEL Newsletter

Dear shareholders, friends,The extraordinary times in which we are living have affected all continents. Each life lost has been one too many. I cannot express enough empathy to our Italian medical colleagues, patients and families …

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Friday, 08 May 2020

Chair Letter to Shareholders

Fellow shareholders,In my March letter I wished all good health during uncertain times. It is now clear the extent of damage COVID-19 has caused and will cause for many years in the future. I want …

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Innovative drug launched for rare, isolating, “light intolerance” disorder Americans living with a rare genetic disorder that forces them to choose between self-isolation in the dark, or burning reactions from exposure to light, are welcoming an …

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1 SCENESSE® (afamelanotide 16mg) is approved in the European Union as an orphan medicinal product for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). SCENESSE® is approved in the USA to increase pain free light exposure in adult EPP patients with a history of phototoxicity. Information on the product, including the approved prescribing information, can be found on CLINUVEL’s website at www.clinuvel.com.

2 Biolcati et al. (2015). Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyria. The British Journal of Dermatology. 172(6), 1601–1612. Langendonk et al. (2015). Afamelanotide for Erythropoietic Protoporphyria. The New England Journal of Medicine. 373(1), 48–59. Wensink et al. (2020). Association of Afamelanotide With Improved Outcomes in Patients With Erythropoietic Protoporphyria in Clinical Practice. JAMA Dermatology. EPub 18 March 2020.

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CLINUVEL PHARMACEUTICALS LTD today announced that US insurance companies have agreed to reimburse SCENESSE® (afamelanotide) for patients diagnosed with erythropoietic protoporphyria (EPP).1SCENESSE® was approved by the US Food and Drug Administration (FDA) in October 2019 …

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2 Further details and terms and conditions are available from www.scenesse.com. This site is intended for US residents only.

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Monday, 23 March 2020

CLINUVEL Kommuniqué II

Sehr geehrte Aktionäre, liebe Freunde,im Laufe des Jahres haben wir einen deutlichen Rückgang der globalen Aktienmärkte erlebt, der den Wertverlust von CLINUVEL noch verstärkt hat. Obwohl dies für viele unserer Aktionäre, einschließlich der Mitarbeiter, die …

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Thursday, 19 March 2020

CLINUVEL Newsletter

Dear shareholders, friends,As the year unfolds, we have witnessed the significant downturn of global stock markets which has compounded the decline of CLINUVEL’s value. While regretful and painful for many of our shareholders, including staff …

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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 …

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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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