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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 […]

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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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Thursday, 23 July 2020

Kommuniqué IV

Liebe Aktionäre, Freunde,Es stellt sich eine neue Welt dar, die darauf hinweist, dass das Virus nicht so leicht zu beseitigen sein wird. Waehrend wir es akzeptieren, einen Modus der Koexistenz zu finden, muessen wir für …

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Wednesday, 22 July 2020

CLINUVEL Newsletter

Communiqué IV, 2020 – 22 July 2020 Dear shareholders, friends,As a new world presents itself indicating that the virus will not easily be eliminated as we are accepting to find a modus co-existentiae, albeit we …

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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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