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Friday, 22 June 2018

Trading Halt

22 June 2018   Pursuant to Listing Rule 17.1, Clinuvel Pharmaceuticals Ltd (CUV) requests an immediate trading halt with respect to its ordinary shares listed on the ASX.   Download PDF for more

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Friday, 01 June 2018

Appendix 3B

01 June 2018   Enclosed is a new issue announcement regarding an application for quotation of additional securities and agreement.   Download PDF for more 

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23 May 2018   CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) today announced that the English National Institute of Health and Care Excellence (NICE) maintained its position not to recommend CLINUVEL’s drug SCENESSE® (afamelanotide 16mg) for reimbursement in England (see ASX announcement 21 December 2017). In its evaluation of novel medicinal […]

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Thursday, 17 May 2018

Change in substantial holding

17 May 2018   Enclosed is a notice of a change in substantial holding of a shareholder   Download PDF for more 

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Wednesday, 16 May 2018

Change in substantial holding

Change in substantial holding Download attachments: 20180516Changeinsubstantialholding.pdf

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Monday, 14 May 2018


14 May 2018   CLINUVEL PHARMACEUTICALS LTD  today provided an update on its global programs to facilitate access to treatment for patients with the ultra-rare genetic disorder erythropoietic protoporphyria (EPP): European Annual and Periodic Reports show positive benefit-risk and safety profile maintained SCENESSE® implants administered globally to date: >5,100 (>4,000 to EPP patients) >99% treatment compliance rate […]

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Tuesday, 01 May 2018

Change in substantial holding

01 May 2018   Enclosed is a notice of a change of interests of a substantial holder.   Download the PDF for more

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01 May 2018   CLINUVEL PHARMACEUTICALS LTD today announced that it has entered into an agreement to acquire 18% of the joint venture established in 2014 between CLINUVEL and Biotech Lab Singapore Pte Ltd (BLS). With this transaction CLINUVEL will gain 100% ownership of VALLAURIX in Singapore: CLINUVEL Group to acquire 18% of Singaporean joint venture […]

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Monday, 30 April 2018

Appendix 4C

30 April 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 disorders, today announced its Appendix 4C – Quarterly Cashflow report for the period 01 January to 31 March 2018.   Download PDF for […]

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Monday, 26 March 2018

CLINUVEL Newsletter – March 2018

26 March 2018   The erythropoietic protoporphyria (EPP) Expert Meeting in Vienna on 16 March has had quite an impact on our global teams working in the fields of photomedicine and melanocortins. The interest in SCENESSE® (afamelanotide 16mg)1 was high and, without exception among all delegates from 12 countries and 21 expert centres, the feedback […]

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19 March 2018   CLINUVEL PHARMACEUTICALS LTD today announced the results of the third European meeting on erythropoietic protoporphyria (EPP) held in Vienna, Austria, on Friday 16 March. Physicians and medical staff from 12 countries and 21 European EPP expert centres discussed the ongoing treatment of adult patients diagnosed with EPP, the post-authorisation obligation for collection […]

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28 February 2018   CLINUVEL PHARMACEUTICALS LTD today announced financial results for the half year ended 31 December 2017, reporting net profit after tax of A$1.41m, and total revenues of A$7.19m: total revenues: A$7.19 million 3% increase in total revenues PRP commercial sales revenues: A$5.33 million cash increase from 30 June 2017: A$4.19 million net profit […]

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Tuesday, 13 February 2018

CLINUVEL unveils new global positioning

20 February 2018   CLINUVEL PHARMACEUTICALS LTD today released its new global Company positioning including the unveiling of a new Group identity and website. The global identity reflects both the Group’s values and evolution as it focusses its research and development on complementary product lines with a theme on “the interaction of human skin with its […]

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Monday, 12 February 2018

CLINUVEL Newsletter – February 2018

12 February 2018   We started this year with limitless optimism and energy, and I attribute this to a foundation of internal changes made over the past 16 months. Our fascinating journey is marred with frequent need to reflect on how to anticipate and respond to a ceaseless flow of changes in CLINUVEL’s clinical, regulatory […]

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Wednesday, 31 January 2018

Appendix 3X – Karen Agersborg

31 January 2018   Enclosed is an initial director’s interest notice.   Download PDF for more

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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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