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20 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

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Tuesday, 11 September 2018

Appendix 3B

11 September 2018   New issue announcement, application for quotation of additional securities and agreement.   Download PDF to read more

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10 September 2018   CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) presented to the BioCentury NewsMakers conference in New York on Friday 07 September. A copy of the presentation and speaking notes is appended.    Download PDF for more

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Wednesday, 05 September 2018

US FDA Update

05 September 2018   CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) today announced that the US Food and Drug Administration (FDA) has issued a request for further documentation to support CLINUVEL’s new drug application (NDA) for SCENESSE® (afamelanotide 16mg). This additional information covers product manufacturing information and details from the European […]

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Tuesday, 04 September 2018

Change in substantial holding

04 September 2018   Enclosed is a notice of change of interests of substantial change holders.   Download PDF for more

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Wednesday, 29 August 2018

Notification of dividend / distribution

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Wednesday, 29 August 2018

CLINUVEL declares first time dividend

29 August 2018   CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) is pleased to announce that it will issue a dividend for the first time in its history for the 12-month financial reporting period ended 30 June 2018. Subject to the Company maintaining sufficient reserves, the Board of Directors have agreed […]

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29 August 2018   The Directors of the Board present their report on the Company and its controlled entities (‘Group’) for the financial year ended 30 June 2018 and the Auditor’s Independence Declaration thereon.   Download PDF to read more

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Tuesday, 21 August 2018

CLINUVEL Investor Summary

21 August 2018   Increasing interest has been seen in the interaction between the human body and non-ionising radiation, part of the emerging field of photomedicine. During the latter decades of the last century the scientific community first began to grasp the short- and long-term impacts of acute and chronic exposure to invisible ultraviolet (UV) […]

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Monday, 30 July 2018

Appendix 4C

30 July 2018   CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY), 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 April to 30 June 2018. All […]

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Friday, 27 July 2018

CLINUVEL Newsletter – July 2018

27 July 2018   On 25 June 2018 CLINUVEL announced its New Drug Application (NDA) for SCENESSE® (afamelanotide 16mg) for adult erythropoietic protoporphyria (EPP) patients had been submitted to the US Food and Drug Administration (FDA). It has been imperative for our teams to thoroughly prepare the scientific write-up and analyses of the use of […]

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Tuesday, 17 July 2018

Change in substantial holding

17 July 2018 Enclosed is a notice of a change of interest of a  substantial shareholder. Download PDF for more 

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6 July 2018   Enclosed is a change in director’s interest notice.    Download PDF for more

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Wednesday, 04 July 2018

Change in substantial holding

04 July 2018   Enclosed is a notice of a change in substantial holding of a shareholder.   Download PDF for more

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25 June 2018   EXECUTIVE SUMMARY First NDA for SCENESSE® (afamelanotide 16mg) in the United States First-line therapy proposed as systemic photoprotection for EPP patients Submission of data from five clinical trials in EPP, pooled data, Compassionate Use, Special Access Schemes, and real-world experience from European use Nearly 6,700 afamelanotide doses administered to more than […]

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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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