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09 August 2017 Enclosed is a notice of a change of interests of a substantial holder. Download PDF for more

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Sunday, 30 July 2017

Appendix 4C – Quarterly report

31 July 2017   The Appendix 4C lodged earlier today reported in item 4.2 a “Net cash from / (used in) operating activities” result of (4,626) for the current quarter. This number should read 4,626, as referred to in item 1.9. Furthermore, item 4.5 “Effect of movement in exchange rates on cash held” should read […]

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Monday, 24 July 2017

CLINUVEL Newsletter – July 2017

10 July 2017   For those who have followed the Company over the years, the journey of our teams has most often been countercurrent to arrive at the present point. Rather than traversing along the fastest imaginable and plotted route to success, we have frequently been impelled to take tortuous avenues to achieve our objectives. […]

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Wednesday, 10 May 2017

Appendix 3B

10 May 2017   enclosed is a new issue announcement, application for quotation of additional securities and agreement.   Download PDF for more

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Wednesday, 10 May 2017

CLINUVEL Newsletter – May 2017

10 May 2017   I look back at a turbulent period, as CLINUVEL has brought the ‘negotiations’ with GKV-Spitzenverband (National Association of Statutory Health Insurance Funds in Germany) to a successful end. Key observations from this procedure are that insurers are coordinating efforts internationally to cull healthcare costs, and will come up with any conceivable […]

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Monday, 01 May 2017

NICE ENGLAND UPDATE ON SCENESSE®

2 May 2017   CLINUVEL PHARMACEUTICALS LIMITED today announced that the Department of Health (DoH) has designated SCENESSE® (afamelanotide 16mg) to be evaluated as a Highly Specialised Technology (HST). The re-classification acknowledges that the National Institute for Health and Care Excellence (NICE) committed an error in its earlier assessment of SCENESSE® as only eligible for […]

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Thursday, 27 April 2017

Appendix 4C – Quarterly report

28 April 2017   CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY), a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic and skin disorders announced today its Appendix 4C – Quarterly Cashflow report for the period ended 31 March 2017.   Download […]

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  12 April 2017   CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION 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     […]

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12 April 2017   CLINUVEL today announced that it had reached agreement with the German National Association of Statutory Health Insurance Funds (GKV-Spitzenverband or GKV-SV) for the treatment of erythropoietic protoporphyria (EPP) patients with CLINUVEL’s drug SCENESSE®    CLINUVEL had been in mandatory ‘negotiation’ with GKV-SV since August 2016. Under the German Pharmaceuticals Market Reorganisation […]

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Friday, 24 February 2017

Appendix 4D and Half Year Report

24 February 2017   Your Directors present their report on the Company and its controlled entities for the half year ended 31 December 2016. The result from ordinary activities attributable to CLINUVEL PHARMACEUTICALS LIMITED for the half year was a net profit of $2,522,519, representing a 177% improvement to the financial result for the same […]

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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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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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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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