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8 November 2016  CLINUVEL today announced that it met on 7 November with the US Food and Drug Administration’s (FDA’s) Division of Dermatology and Dental Products (DDDP) to discuss the content and format of a new drug application (NDA) submission as part of the US regulatory pathway for CLINUVEL’s medicinal product SCENESSE® (afamelanotide 16mg). The pharmaceutical […]

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Monday, 31 October 2016

Response to Price Query

31 October 2016   Enclosed is CLINUVEL PHARMACEUTICALS LTD’s response to a price query lodged by the ASX.   Download PDF for more

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Monday, 31 October 2016

Appendix 4C

31 October 2016   Enclosed is the quarterly report for the period ending 30 September 2016.   Download PDF for more

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Wednesday, 26 October 2016

Notice of Annual General Meeting/Proxy Form

26 October 2016   This Explanatory Memorandum has been prepared for the Shareholders of the CLINUVEL PHARMACEUTICALS LIMITED ACN 089 644 119 in connection with the business to be conducted at the annual general meeting of Shareholders of the Company which will be held at: Location Karstens Conference Centres, 123 Queen Street, Melbourne, Victoria, Australia […]

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Wednesday, 26 October 2016

Appendix 4G

26 October 2016   Enclosed is the Corporate Governance Council Principles and Recommendations as at 27 October 2016.    Download PDF for more

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Saturday, 22 October 2016

CLINUVEL relocates Melbourne office

24 October 2016   CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY) today announced that its head office in Melbourne has relocated.   Download PDF for more

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24 October 2016   The US Food and Drug Administration (FDA) will today host a scientific workshop on erythropoietic protoporphyria (EPP) at the FDA campus in Silver Spring. The workshop is open to all EPP stakeholders, with the FDA seeking perspective on EPP disease symptoms, its impact on daily life, experience with current treatment regimens […]

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Sunday, 16 October 2016

SCENESSE® NICE ENGLAND UPDATE

18 October 2016    CLINUVEL [ASX: CUV; Nasdaq International Designation ADR: CLVLY; Xetra-DAX: UR9] today announced an update on the review by National Institute for Health and Care Excellence (NICE) regarding its drug SCENESSE® (afamelanotide 16mg) for adult patients with erythropoietic protoporphyria (EPP) in England. On 24 March 2016 CLINUVEL announced it had participated in a public […]

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12 October 2016   On 7 November the US Food and Drug Administration (FDA) will hold a meeting with CLINUVEL to discuss the submission a New Drug Application (NDA) for SCENESSE® (afamelanotide 16mg) in the treatment of erythropoietic protoporphyria (EPP). Executive summary: The FDA scheduled a pre-NDA1 meeting on 7 November to discuss CLINUVEL’s planned […]

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11 October 2016   CLINUVEL PHARMACEUTICALS LTD today announced that it will meet with the US Food and Drug Administration (FDA) on 7 November to formally discuss lodging its new drug application (NDA) for the novel drug SCENESSE® (afamelanotide 16mg). The pre-NDA meeting will focus on finalising requirements for filing SCENESSE® with the FDA for […]

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09 October 2016   In accordance with ASX listing rules 3.13.1 and 14.3, CLINUVEL PHARMACEUTICALS LIMITED [ASX: CUV; Nasdaq International Designation ADR: CLVLY; Xetra-DAX: UR9] today announced it will hold its 2016 Annual General Meeting of shareholders on Monday November 28, 2016 at 10.00am AEST at Karstens Conference Centres, 123 Queen Street, Melbourne, Victoria, Australia […]

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Monday, 19 September 2016

Chair’s Letter

19 September 2016   This summer our team supplied the first SCENESSE® (afamelanotide 16mg) treatment for erythropoietic protoporphyria (EPP) patients in the Netherlands and Austria. It has been a long journey and our gratitude goes to the forbearance of patients, physicians, and shareholders alike in supporting the efforts of a dedicated Clinuvel staff, who must […]

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24 August 2016   Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) is a global biopharmaceutical company focused on developing drugs for the treatment of a range of severe skin disorders. With its unique expertise in understanding the interaction of light and human skin, the Company has identified patients with a clinical need for […]

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23 August 2016   CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) wishes to advise in accordance with the terms and conditions of issue that the following unquoted conditional performance rights have lapsed and forfeited: Class Number Exercise price CUVAK Conditional Performance Rights subject to various performance milestones, issued various dates under the 2009 […]

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Sunday, 14 August 2016

CLINUVEL Newsletter – August 2016

16 August 2016   In the arduous journey from explorative concept to development to commercial availability of the novel molecular entity – SCENESSE® afamelanotide 16mg)1 – one may become engrossed in the processes leading to the desired outcome. The ultimate goal of changing people’s lives is what drives us at Clinuvel and our team is […]

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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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