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Wednesday, 15 February 2017

CLINUVEL Newsletter – February 2017

16 February 2017   I wish all stakeholders of the CLINUVEL Group a healthy, mindful and successful 2017. After a Christmas break CLINUVEL started 2017 with fervour and ‘en bon esprit’. We look forward to an exciting year. During a meeting on 4 February in London international expert physicians, senior and paediatric patients, family carers […]

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Tuesday, 31 January 2017

Appendix 4C – Quarterly report

31 January 2017   Enclosed is the quarterly report for the period ending 31 December 2016.   Download PDF for more

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Thursday, 22 December 2016

Appendix 3Y

22 December 2016   We (the entity) give ASX the following information under listing rule 3.19A.2 and as agent for the director for the purposes of section 205G of the Corporations Act.   Download PDF for more

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Tuesday, 20 December 2016

CLINUVEL Newsletter – December 2016

20 December 2016   At the end of a calendar year we look back on plenty of activities and a solid financial performance by the CLINUVEL Group. Our teams will break over the season’s holidays to reflect on a hectic year, but most of all to prepare ourselves physically and mentally for more exciting challenges […]

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Monday, 12 December 2016

Appendix 3Y

12 December 2016   We (the entity) give ASX the following information under listing rule 3.19A.2 and as agent for the director for the purposes of section 205G of the Corporations Act.   Download PDF for more

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Monday, 28 November 2016

Results of Meeting

28 November 2016 In accordance with Listing Rule 3.13.2 and section 251AA of the Corporations Act, we advise details of the resolutions and the proxies received in respect of each resolution are set out in the attached proxy summary. Download PDF for more

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27 November 2017   I would like to commence my address by saying it is always a pleasure to welcome familiar and a few new faces to the CLINUVEL Annual General Meeting. It has indeed been quite a journey since the early 2000’s, working in an environment of constant change requiring repeated changes of direction […]

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Sunday, 27 November 2016

Managing Director’s AGM Presentation

27 November 2016   Good morning and welcome to CLINUVEL’s Annual General Meeting. The challenges ahead for 2017 are to reconcile the asymmetry in knowledge with regulators, governmental advisory bodies, payors, medical community and press on CLINUVEL’s innovative technology SCENESSE® (afamelanotide 16mg)1 and to differentiate CLINUVEL from other companies in our sector.   Download PDF […]

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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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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 …

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Thursday, 02 May 2019

CLINUVEL Newsletter

02 May 2019  Dear patients, shareholders, friends,In this Communiqué we concentrate on CLINUVEL’s programs and US market access for SCENESSE®.As the European season unfolds, we report on the back of quarterly financials (released 30 April) …

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Wednesday, 24 April 2019

Chair Letter to Shareholders

24 April 2019   Dear All,On a continent where very few biotechnology and pharmaceutical companies have ever succeeded in taking a first-in-class and first-in-line therapy from concept to commercialisation, CLINUVEL has all the makings of becoming …

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Wednesday, 20 March 2019

CLINUVEL Newsletter – March 2019

20 March 2019  Dear patients, shareholders, friends,In the third Communiqué we are reviewing our EU operations, the impact of Brexit and looking at the year ahead. FDA REVIEWAt the time of print CLINUVEL will find itself …

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Tuesday, 12 February 2019

CLINUVEL Vitiligo Communiqué II

12 February 2019   In the second Communiqué we look closer at the role of narrowband UVB (NB-UVB) as the only standard of care at present in vitiligo, both the segmental and generalised form of the disease. …

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Tuesday, 15 January 2019

CLINUVEL Newsletter - January 2019

15 January 2019 Dear patients, shareholders, friends,I wish you all a year in good physical and spiritual health, and a year in which we anticipate further progress of SCENESSE ® (afamelanotide 16mg)1 and CLINUVEL’s other products …

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Thursday, 10 January 2019

US FDA sets PDUFA date for SCENESSE®

Melbourne, Australia 10 January 2019 Priority Review granted for innovative drug, PDUFA date 8 July 2019  Executive summary New Drug Application submitted in accordance with section 505(b) of the Federal Food, Drug, and Cosmetic Act, filed in …

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Wednesday, 19 December 2018

CLINUVEL Vitiligo Communiqué

19 December 2018 As a depigmentation disorder (hypomelanosis), vitiligo is the most well-known of all leucodermatoses (“white skin”) whereby other variants of loss of skin pigmentation – temporary or permanent - are described as albinism, piebaldism, …

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Monday, 17 December 2018

CLINUVEL Newsletter - December 2018

17 December 2018 As the year draws to a close we look back at a hectic, yet successful, 12 months. In CLINUVEL’s marathon, the past year looked like a series of endless sprints to accomplish all we had …

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Monday, 05 November 2018

CLINUVEL Newsletter - November 2018

05 November 2018 The most recent quarterly financial results (1 July-30 September 2018) confirm the steady growth in clinical demand for SCENESSE® (afamelanotide 16mg) in erythropoietic protoporphyria (EPP), a rare genetic metabolic disorder.1 EPP is classified …

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