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Wednesday, 13 March 2019

Change in substantial holding

13 March 2019   Form 604Corporations Act 2001Section 671BNotice of change of interests of substantial holder   Download PDF to read more

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13 March 2019   Change of Director’s Interest Notice   Download PDF to read more

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Wednesday, 13 March 2019

Appendix 3B

13 March 2019   New issue announcement, application for quotation of additional securities and agreement   Download PDF to read more

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Monday, 04 March 2019

Investor Briefing

4 March 2019 Investor Briefing – Non-Deal Roadshow Download PDF to read more

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Tuesday, 26 February 2019

Appendix 4D Half Yearly Report

Melbourne, Australia, 26 February 2019 CLINUVEL PHARMACEUTICALS LTD, a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic and skin disorders, today announced its Appendix 4D – Half Yearly Report for the period 01 July to 31 December 2018. All figures are rounded and reported in Australian […]

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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. Although it is widely accepted in photodermatology that NB-UVB is not a reliable and effective therapy for vitiligo, […]

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Thursday, 07 February 2019

CLINUVEL Newsletter – February 2019

7 February 2019 Dear patients, shareholders, friends, In this second Communiqué for the year we will delve deeper in the ongoing treatment of erythropoietic protoporphyria (EPP) patients in Europe and look ahead at the expected news flow from the US Food and Drug Administration (FDA) in the coming months. Gradually, we are sharing the contours […]

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Thursday, 31 January 2019

Appendix 4C

31 January 2019   Melbourne, Australia and Leatherhead, UK   CLINUVEL PHARMACEUTICALS LTD, a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic and skin disorders, today announced its Appendix 4C – Quarterly Cashflow report for the period 01 October to 31 December 2018. All figures are […]

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Tuesday, 29 January 2019

Change of Director’s Interest Notice

Melbourne, Australia 29 January 2019 The following Appendix 3Y Change of Director’s Interest Notice relates to a notifiable interest in CLINUVEL PHARMACEUTICALS LTD for Mrs Brenda Shanahan. There has been no recent trading activity by Mrs Shanahan but the updated notice now includes 80,000 shares held in a charitable foundation of which Mrs Shanahan is […]

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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 and activities. We look to a rather full year of events affecting CLINUVEL in one way or […]

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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 accordance with 21 CFR 314.101(a) Scientific exchange between FDA and CLINUVEL continues under Priority Review FDA expects to […]

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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, pityriasis alba, tuberous sclerosis, idiopathic guttate hypomelanosis and tinea versicolor. The precise mechanism which leads to generalised loss […]

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19 December 2018   Summary • n=21, patients of Asian ethnicity, darker skin complexion• Pooled analysis of data collected on all patients who received SCENESSE® with NB-UVB (n=18)• Six doses of SCENESSE® subcutaneously administered monthly in combination with NB-UVB twice a week• Repigmentation therapy with SCENESSE® in combination with NB-UVB effective and safety profile maintained:  […]

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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 put on our corporate agenda. I thank our teams for the incessant work this year; without it patients […]

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Wednesday, 21 November 2018

Results of Meeting

21 November 2018 In accordance with Listing Rule 3.13.2 and section 251AA of the Corporations Act, we advise details of the resolutions and the proxies received in respect of each resolution are set out in the attached proxy summary.  Download PDF to read more

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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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