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20 June 2016   First commercial delivery, SCENESSE® approved as standard of care in the Netherlands. CLINUVEL Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that its drug SCENESSE® (afamelanotide 16mg) has been launched in Europe, with the first commercial delivery of the product under European marketing authorisation. Patients with the rare genetic disorder […]

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 31 May 2016   CLINUVEL Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced the inclusion of its Sponsored Level 1 American Depository Receipt (ADR) program in Nasdaq’s International Designation, a new visibility offering available to non-US companies. CLINUVEL is the first life science company to be selected for this initiative, first launched by […]

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Tuesday, 17 May 2016

SCENESSE® treatment in Europe

17 May 2016   German Porphyria Expert Centres to start distribution of SCENESSE® (afamelanotide 16mg) Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced an update on the company’s post-authorisation distribution of SCENESSE® (afamelanotide 16mg) across Europe for adult patients with the rare disorder erythropoietic protoporphyria (EPP).   Download PDF for more

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Friday, 29 April 2016

Appendix 4C – Q3 FY16

29 April 2016   Enclosed is a copy of the quarterly report for the period ending 31 March 2016.   Download PDF for more

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Monday, 11 April 2016

Form 604

11 April 2016   Enclosed is a notice of change of interests of substantial holder   Download PDF for more

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Monday, 04 April 2016

CLINUVEL Newsletter – April 2016

4 April 2016   Clinuvel is arriving at a point many of our patients and investors have longed for: first commercial treatment for EPP patients. Last month our European teams conducted a number of training and accreditation visits at European Hospitals. The purpose of these site visits was to instruct staff, management and clinical personnel […]

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23 March 2016   NICE’s technical team invited stakeholders with an interest in the treatment of erythropoietic protoporphyria (EPP) Executive summary SCENESSE® evaluated as part of the Highly Specialised Technologies Programme (HST) in UK HST Programme review of relatively high cost – low volume technology Evaluation of the drug as an innovative therapy for unmet […]

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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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Wednesday, 29 January 2020

CLINUVEL Kommuniqué I

Sehr geehrte Aktionärinnen und Aktionäre, liebe FreundeIm Namen des CLINUVEL-Ausschusses wünsche ich Ihnen allen ein gutes neues Jahr in der Hoffnung, dass es Ihnen Gesundheit und Wohlstand verleiht. Wir bedanken uns vielmals bei Stan McLiesh, …

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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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