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Wednesday, 28 August 2019

CLINUVEL Clarifies ex-Dividend Date

  In relation to the dividend announcement earlier today, CLINUVEL PHARMACEUTICALS LTD clarifies the ex-dividend date is to be 04 September 2019. Download PDF

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Wednesday, 28 August 2019

CLINUVEL Declares Final Dividend

  CLINUVEL PHARMACEUTICALS LTD is pleased to announce that it will issue a dividend for the financial year ended 30 June 2019. This is the second final dividend in its corporate history. […] Download PDF

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  CLINUVEL PHARMACEUTICALS LTD (CLINUVEL), 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 4E and Preliminary Financial Report for the year ending 30 June 2019. […] Download PDF

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  CLINUVEL PHARMACEUTICALS LTD today announced that its program in systemic photoprotection will be discussed and presented at the first European-American meeting of the International Congress on Photobiology and Congress of the European Society for Photobiology, Light and Life, held in Barcelona, Spain, from 25-30 August. […] Download PDF

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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. […] Download PDF

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Wednesday, 31 July 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 April to 30 June 2019.   Download PDF

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  CLINUVEL PHARMACEUTICALS LTD today announced that non-executive Director, Willem Blijdorp has replaced Managing Director and Chief Executive Officer, Dr Philippe Wolgen as a member of the Audit & Risk Committee. […] Download PDF

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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 SCENESSE® (afamelanotide 16mg) by three months […] Download PDF

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   21 June 2019      Download PDF

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CLINUVEL INCLUDED IN S&P/ASX 200 INDEX 14 June 2019 Download PDF    

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6 June 2019   Download PDF

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Melbourne, Australia 5 June 2019 Download PDF

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Melbourne, Australia 3 June 2019 Download PDF The FDA sets new goal date of 6 October 2019 to complete review and issue risk-benefit decision CLINUVEL PHARMACEUTICALS LTD today published that the US Food and Drug Administration (FDA) Division of Dermatology and Dental Products (DDDP) has set a new Prescription Drug User Fee Act (PDUFA) goal […]

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Melbourne, Australia 3 June 2019 Download PDF The FDA sets new goal date of 6 October 2019 to complete review and issue risk-benefit decision   Executive summary New PDUFA goal date set for 6 October 2019 New timeline to communicate labelling changes and post-marketing commitments by 6 September 2019 Scientific exchange between FDA and CLINUVEL […]

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15 May 2019   Download PDF

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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 …

www.clinuvel.com

 

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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