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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 […]
Download PDF21 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 […]
Download PDF05 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 […]
Download PDFAppendix 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 […]
Download PDF29 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 […]
Download PDF18 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 […]
Download PDF18 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
Download PDF10 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 […]
Download PDF08 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
Download PDF05 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 […]
Download PDF04 October 2018 This is a notice regarding an individual or entity ceasing to be a substantial shareholder. Download PDF for more
Download PDF03 October 2018 CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) today announced it will hold its 2018 Annual General Meeting of shareholders on Wednesday 21 November 2018 at 10.00am AEDT at The Events Centre at Collins Square, Tower 2, Level 6, 727 Collins Street, Melbourne, VIC 3008 Australia. Downlaod […]
Download PDF01 October 2018 CLINUVEL PHARMACEUTICALS LTD today announced that it has reached agreement with two European porphyria expert centres on a clinical trial protocol to conduct a Phase IIa proof of concept study evaluating the safety and effectiveness of SCENESSE® (afamelanotide 16mg) in variegate porphyria (VP). The study (CUV040) will start patient treatment in […]
Download PDF20 September 2018 CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) presented to the Nasdaq Virtual Investor Conference on Wednesday 19 September. A copy of the presentation is appended. Download PDF to read more
Download PDF11 September 2018 New issue announcement, application for quotation of additional securities and agreement. Download PDF to read more
Download PDF02 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) …
Download PDF24 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 …
Download PDF20 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 …
Download PDF12 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. …
Download PDF15 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 …
Download PDFMelbourne, 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 …
Download PDF19 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, …
Download PDF17 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 …
Download PDF05 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 …
Download PDF05 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. …
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