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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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10 October 2018   CLINUVEL PHARMACEUTICALS LTD today announced that the Appeal Panel of the National Institute of Health and Care Excellence (NICE) – the body responsible for providing evidence-based guidance on health and social care to the National Health Service (NHS) in England – has published a decision following an oral Appeal Hearing as […]

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08 October 2018   CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) presented at the Sachs 18th Biotech in Europe Forum on Thursday 04 October. A copy of the presentation is appended.   Download PDF for more

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Friday, 05 October 2018

Chair Letter to Shareholders

05 October 2018   This is a thank you to shareholders, investors, patients, clinicians, and all those who have continued to support CLINUVEL together with new shareholders who have recently gained confidence to join the CLINUVEL register. The Company’s performance of the past years, the first ever dividend declared, and progress towards US market entry […]

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