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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

CLINUVEL REGULATORY UPDATE

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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Wednesday, 31 January 2018

Appendix 4C

31 January 2018 Melbourne, Australia and Leatherhead, UK 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 and therapeutically unmet genetic disorders today announced its Appendix 4C – Quarterly Cashflow report for the period 01 […]

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Monday, 29 January 2018

CLINUVEL appoints US based Director

29 January 2018   CLINUVEL PHARMACEUTICALS LTD  today announced the appointment of Dr Karen Agersborg as a Non-Executive member of the Group’s Board of Directors. Dr Agersborg is a Board-Certified Endocrinologist in Pennsylvania, USA, currently serving as Clinical Endocrinologist at Reading Hospital, specialising in Endocrinology, Diabetes & Metabolism. Dr Agersborg had previously worked at Suburban Hospital, […]

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Wednesday, 10 January 2018

Chair Letter to Shareholders

11 January 2018   Whilst the Board of CLINUVEL looks back on a very successful 2017 it must now look forward to exciting times ahead. The Group will engage in many activities on several continents, and we are expecting to see the first fruits of internal research coming to the public eye.    Download PDF […]

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21 December 2017 CLINUVEL PHARMACEUTICALS LTD today announced that the first draft assessment from England’s National Institute for Health and Care Excellence (NICE) has been published, with SCENESSE® (afamelanotide 16mg) not recommended for reimbursement for the ultra-orphan disorder erythropoietic protoporphyria (EPP), subject to NICE’s final recommendation expected in May 2018. SCENESSE® is the only approved […]

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Thursday, 16 January 2020

CLINUVEL Newsletter

Dear shareholders, friendsOn behalf of the CLINUVEL Board, I wish you all a good new year in the hope that it confers you with good health and prosperity, in that particular sequence. We thank and …

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Thursday, 05 December 2019

Appendix 3B

 New issue announcement, application for quotation of additional securities and agreement. 

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Monday, 02 December 2019

CEO Letter

Dear shareholders, On 8 October 2019, CLINUVEL obtained its first and historic US Food and Drug Administration (FDA) approval, some 39 years since the afamelanotide technology was first discovered in a university laboratory. On this day …

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Dearest Shareholders, As the incoming Chair of the Company, in short letters I will try to provide you with updates and inform you about our business.[...]

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 CLINUVEL PHARMACEUTICALS LTD today announced that Mr Stan McLiesh will retire from his role as Non-Executive Director and Chair of the Board on 30 November 2019. Non-Executive Director Mr Willem Blijdorp has been elected Chair …

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Thursday, 17 October 2019

CLINUVEL Newsletter

  In this News Communiqué VII, we pause to reflect on the outstanding US regulatory outcome and look back one last time at all the events which led to the long-desired outcome on 8 October, the …

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Tuesday, 15 October 2019

Chair Letter to Shareholders

  Dear All, In my career in life sciences, I have served on public Boards, was part of the management team that led CSL to its position and oversaw several executive transitions in our beloved Company, first …

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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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