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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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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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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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Friday, 05 October 2018

Chair Letter to Shareholders

05 October 2018 This is a thank you to shareholders, investors, patients, clinicians, and all those who have continued to support CLINUVEL together with new shareholders who have recently gained confidence to join the CLINUVEL register. …

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