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Thursday, 12 March 2020

Chair Letter to Shareholders

Fellow shareholders, Let me start a first welcome letter by wishing you a successful and great year ahead without health issues, pertinent at the time that Corona virus is taking over the world news. Since appointed in my position I have taken on the task to oversee our Company, one with immense potential. The first […]

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CLINUVEL PHARMACEUTICALS LTD [ASX:CUV; XETRA-DAX: UR9; Nasdaq International Designation: CLVLY] today received confirmation that the US Food and Drug Administration (FDA) has designated 29 April to discuss and agree the North American development program for SCENESSE® (afamelanotide 16mg) for the pigment loss disorder vitiligo.1 PROPOSED STUDIES CUV104 AND CUV105 IN NORTH AMERICA   The proposed […]

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CLINUVEL PHARMACEUTICALS LTD today communicated in response to a number of public queries that neither the drug substance nor the excipients of SCENESSE® (afamelanotide 16mg) are affected by the coronavirus.1 The coronavirus (COVID-19) is a class 1 viral fusion protein and is not affecting the supply chain or manufacturing of SCENESSE®. THE CORONAVIRUS DISEASE (COVID-19) […]

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Thursday, 27 February 2020

Corporate Presentation Half Year Results

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Wednesday, 26 February 2020

Appendix 4D Half Yearly Report

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 financial result for the six months ended 31 December 2019. All figures are rounded and reported in Australian dollars. FINANCIAL RESULT CLINUVEL achieved positive results in the half […]

Company Announcement, 10 February 2020. CLINUVEL PHARMACEUTICALS LTD announced it has requested a Type C Guidance meeting with the FDA to seek agreement on the design of a multicentre Phase IIb vitiligo clinical study (CUV104) and the data package necessary to support a supplemental New Drug Application (sNDA) filing for CLINUVEL’s drug SCENESSE® in vitiligo.

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Refer Company Announcement, 24 February 2020. CLINUVEL PHARMACEUTICALS LTD announced it is expanding its Singapore laboratories with the support of a grant from the Singapore Economic Development Board.

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Tuesday, 25 February 2020

Appendix 3B and Appendix 3Y Withdrawn

Melbourne, Australia 25 February 2020   CLINUVEL PHARMACEUTICALS LTD (“Company”) withdraws the Appendix 3B (“Appendix 3B”) and Change of Director’s Interest Notice (“Appendix 3Y”) filed by the Company on 5 December 2019. The Appendix 3B and Appendix 3Y relate to the proposed grant of 1,513,750 unlisted performance rights to the CEO (the “Unlisted Performance Rights”) […]

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Monday, 24 February 2020

CLINUVEL Expands Singapore Laboratories

CLINUVEL PHARMACEUTICALS LTD today announced that it is investing in the further expansion of its facilities in Singapore with new state of the art and expanded laboratories to open 1 July 2020. The research and development capacity of its wholly owned subsidiary, VALLAURIX PTE LTD, will be expanded through both a new biological and analytical […]

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CLINUVEL requests Type C Guidance meeting to progress the clinical program in vitiligo CLINUVEL PHARMACEUTICALS LTD today announced it has requested a Type C Guidance meeting with the US Food and Drug Administration (FDA) to seek agreement on the design of a multicentre Phase IIb vitiligo clinical study (CUV104) and the data package necessary to […]

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EXECUTIVE SUMMARY SCENESSE® (afamelanotide 16mg) technology review starts in Australia for rare disease EPP Priority Review aims at a technology review timeframe of 150 working days Advisory Committee on Medicines may be required during the review of SCENESSE®[…] Download PDF  

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Friday, 31 January 2020

Appendix 4C

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 2019. All figures are rounded and reported in Australian dollars[…]  

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Wednesday, 29 January 2020

CLINUVEL Kommuniqué I

Sehr geehrte Aktionärinnen und Aktionäre, liebe Freunde Im 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, der am 30. November 2019 nach 17 Dienstjahren in den Ruhestand getreten ist. Wir begrüßen Willem Blijdorp als neuen […]

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Thursday, 16 January 2020

CLINUVEL Newsletter

Dear shareholders, friends On 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 owe much to Stan McLiesh who retired on November 30 2019 after 17 years of service, we welcome Willem […]

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CLINUVEL initiates the registration process under priority review for its new pharmaceutical drug.   CLINUVEL PHARMACEUTICALS LTD today announced that it has submitted an application to the Australian Therapeutic Goods Administration (TGA) for its drug SCENESSE® (afamelanotide 16mg) to be registered in the Australian Register of Therapeutic Goods (ARTG). If registered, SCENESSE® would be made […]

www.clinuvel.com.

 

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  Form 604 – Notice of change of interests of substantial holder is available to download.

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Monday, 09 December 2019

Change of Director’s Interest Notice

Appendix 3Y – Change of Director’s Interest Notice, is available to download.

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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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Friday, 27 July 2018

CLINUVEL Newsletter - July 2018

27 July 2018 On 25 June 2018 CLINUVEL announced its New Drug Application (NDA) for SCENESSE® (afamelanotide 16mg) for adult erythropoietic protoporphyria (EPP) patients had been submitted to the US Food and Drug Administration (FDA). It …

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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 …

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