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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.

3
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, 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 …

www.clinuvel.com.

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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