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Thursday, 31 January 2019

Appendix 4C

31 January 2019   Melbourne, Australia and Leatherhead, UK   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 2018. All figures are […]

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Tuesday, 29 January 2019

Change of Director’s Interest Notice

Melbourne, Australia 29 January 2019 The following Appendix 3Y Change of Director’s Interest Notice relates to a notifiable interest in CLINUVEL PHARMACEUTICALS LTD for Mrs Brenda Shanahan. There has been no recent trading activity by Mrs Shanahan but the updated notice now includes 80,000 shares held in a charitable foundation of which Mrs Shanahan is […]

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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 and activities. We look to a rather full year of events affecting CLINUVEL in one way or […]

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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 accordance with 21 CFR 314.101(a) Scientific exchange between FDA and CLINUVEL continues under Priority Review FDA expects to […]

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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, pityriasis alba, tuberous sclerosis, idiopathic guttate hypomelanosis and tinea versicolor. The precise mechanism which leads to generalised loss […]

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19 December 2018   Summary • n=21, patients of Asian ethnicity, darker skin complexion• Pooled analysis of data collected on all patients who received SCENESSE® with NB-UVB (n=18)• Six doses of SCENESSE® subcutaneously administered monthly in combination with NB-UVB twice a week• Repigmentation therapy with SCENESSE® in combination with NB-UVB effective and safety profile maintained:  […]

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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 put on our corporate agenda. I thank our teams for the incessant work this year; without it patients […]

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Wednesday, 21 November 2018

Results of Meeting

21 November 2018 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 to read more

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Wednesday, 21 November 2018

Managing Director AGM Presentation

21 November 2018 We have enjoyed the longest bull run in equities since the end of WWII, which started on 9 March 2009. In the wake of the surge of global market indices CLINUVEL has enjoyed an appreciation in enterprise value from A$8.64 on 11 November 2017 to A$20.98 on 9 November 2018; this provided CUV a […]

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21 November 2018 The value the market has placed on the Company reflects the progress made throughout this financial year. In June we filed our first new drug application with the US Food and Drug Administration, a milestone not just for CLINUVEL but for the entire biotechnology industry in Australia. While a number of innovations […]

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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 as a condition of high unmet medical need, and for it not to have found any alternative therapy makes […]

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Wednesday, 31 October 2018

Appendix 4C

Appendix 4C Melbourne, Australia and Leatherhead, UK, 31 October 2018 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 July to 30 September 2018. All figures are […]

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 29 October 2018   CLINUVEL PHARMACEUTICALS LTD today announced that its fully owned Singaporean subsidiary VALLAURIX PTE LTD is expanding its laboratory facilities to incorporate a variety of critical analytical functions. As part of the increase in research activities on next generation products, new analytical capacity is being added and will be integrated into the […]

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18 October 2018   This statement reports on the main corporate governance practices of the Company as at 19 October 2018 and it has been approved by the Board of the Company on 29 August 2018. This statement is organised under headings based on the Australian Securities Exchange Corporate Governance Council’s (ASXCGC) Corporate Governance Principles […]

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18 October 2018   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.   Download PDF for more

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Thursday, 05 December 2019

Appendix 3B

 New issue announcement, application for quotation of additional securities and agreement. 

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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 …

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Dearest Shareholders, As the incoming Chair of the Company, in short letters I will try to provide you with updates and inform you about our business.[...]

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 CLINUVEL PHARMACEUTICALS LTD today announced that Mr Stan McLiesh will retire from his role as Non-Executive Director and Chair of the Board on 30 November 2019. Non-Executive Director Mr Willem Blijdorp has been elected Chair …

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Thursday, 17 October 2019

CLINUVEL Newsletter

  In this News Communiqué VII, we pause to reflect on the outstanding US regulatory outcome and look back one last time at all the events which led to the long-desired outcome on 8 October, the …

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Tuesday, 15 October 2019

Chair Letter to Shareholders

  Dear All, In my career in life sciences, I have served on public Boards, was part of the management team that led CSL to its position and oversaw several executive transitions in our beloved Company, first …

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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. [...]

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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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