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Friday, 18 March 2016

s.708A Notice

18 March 2016   Notice under section 708A(5)(e) of the Corporations Act 2001   Download PDF for more

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Friday, 18 March 2016

Appendix 3B

18 March 2016   Enclosed is a new issue announcement, application for quotation of additional securities and agreement   Download PDF for more

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Friday, 18 March 2016

Form 604

18 March 2016   Enclosed is a Notice of Change of Interests of Substantial Holder.   Download PDF for more

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Tuesday, 15 March 2016

Form 604 – March 15, 2016

15 March 2016   Enclosed is a notice of a change of interest of substantial holder.   Download PDF for more

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 13 March 2016   CLINUVEL Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that its European commercial team is conducting site training and accreditation at the first of the European expert porphyria centres this week. Following training these centres of expertise will be accredited to prescribe CLINUVEL’s drug SCENESSE® (afamelanotide 16mg) to adult […]

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13 March 2016   ** Not for release or distribution in the United States ** CLINUVEL Pharmaceuticals Limited has successfully raised A$8.3 million dollars via a private placement (“Placement”) to existing and new international institutional and professional investors.   Download PDF for more

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Friday, 11 March 2016

Request for Trading Halt

11 March 2016   Pursuant to Listing Rule 17.1, Clinuvel Pharmaceuticals Ltd (CUV) requests a trading halt with respect to its ordinary shares from the commencement of trading on Friday 11th March 2016 until the commencement of trading Tuesday 15th March, 2016.   Download PDF for more

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Friday, 19 February 2016

Appendix 4D and Half Year Report

19 February 2016   Your Directors present their report on the company and its controlled entities for the half year ended 31 December 2015.   Download PDF for more

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19 February 2016   CLINUVEL Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced an update on the commercialisation of its novel drug SCENESSE® (afamelanotide 16mg) in adult patients with erythropoietic protoporphyria (EPP) in Europe. CLINUVEL has been working towards finalising distribution infrastructure, with a focus on a Risk Management Plan (RMP) and pharmacovigilance […]

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  10 February 2016   Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that its lead drug SCENESSE® (afamelanotide 16mg) has received an additional orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of cutaneous variants of porphyria. The ODD recognises the potential of afamelanotide to […]

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8 February 2016   Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA‐DAX: UR9; ADR: CLVLY) presented to an international porphyria  patient meeting, held in Rotterdam, the Netherlands, on February 6, 2016. The presentation and speaking notes are  appended to this announcement.   Download PDF for more

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Thursday, 28 January 2016

Appendix 4C – Q2 FY16

28 January 2016   Enclosed is a copy of the Quarterly report for entities admitted on the basis of commitments.     Download PDF for more

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Monday, 25 January 2016

Form 604

25 January 2016   Enclosed is a notice of a change of interest in substantial holder.   Download PDF for more

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Wednesday, 20 January 2016

CEO Brief – January 20, 2016

20 January 2016   Having both received and provided services within the healthcare sector over the years I am all too aware of the peril of compromised health and loss of your livelihood. In Clinuvel’s case we aspire to make our patients realise their dreams and ambitions by making SCENESSE® (afamelanotide 16mg) available to all […]

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Monday, 18 January 2016

Form 604

18 January 2016   Enclosed is a notice of change of interests of a substantial holder.    Download PDF for more

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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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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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