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Sunday, 16 October 2016


18 October 2016    CLINUVEL [ASX: CUV; Nasdaq International Designation ADR: CLVLY; Xetra-DAX: UR9] today announced an update on the review by National Institute for Health and Care Excellence (NICE) regarding its drug SCENESSE® (afamelanotide 16mg) for adult patients with erythropoietic protoporphyria (EPP) in England. On 24 March 2016 CLINUVEL announced it had participated in a public […]

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12 October 2016   On 7 November the US Food and Drug Administration (FDA) will hold a meeting with CLINUVEL to discuss the submission a New Drug Application (NDA) for SCENESSE® (afamelanotide 16mg) in the treatment of erythropoietic protoporphyria (EPP). Executive summary: The FDA scheduled a pre-NDA1 meeting on 7 November to discuss CLINUVEL’s planned […]

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11 October 2016   CLINUVEL PHARMACEUTICALS LTD today announced that it will meet with the US Food and Drug Administration (FDA) on 7 November to formally discuss lodging its new drug application (NDA) for the novel drug SCENESSE® (afamelanotide 16mg). The pre-NDA meeting will focus on finalising requirements for filing SCENESSE® with the FDA for […]

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09 October 2016   In accordance with ASX listing rules 3.13.1 and 14.3, CLINUVEL PHARMACEUTICALS LIMITED [ASX: CUV; Nasdaq International Designation ADR: CLVLY; Xetra-DAX: UR9] today announced it will hold its 2016 Annual General Meeting of shareholders on Monday November 28, 2016 at 10.00am AEST at Karstens Conference Centres, 123 Queen Street, Melbourne, Victoria, Australia […]

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Monday, 19 September 2016

Chair’s Letter

19 September 2016   This summer our team supplied the first SCENESSE® (afamelanotide 16mg) treatment for erythropoietic protoporphyria (EPP) patients in the Netherlands and Austria. It has been a long journey and our gratitude goes to the forbearance of patients, physicians, and shareholders alike in supporting the efforts of a dedicated Clinuvel staff, who must […]

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24 August 2016   Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) is a global biopharmaceutical company focused on developing drugs for the treatment of a range of severe skin disorders. With its unique expertise in understanding the interaction of light and human skin, the Company has identified patients with a clinical need for […]

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23 August 2016   CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) wishes to advise in accordance with the terms and conditions of issue that the following unquoted conditional performance rights have lapsed and forfeited: Class Number Exercise price CUVAK Conditional Performance Rights subject to various performance milestones, issued various dates under the 2009 […]

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Sunday, 14 August 2016

CLINUVEL Newsletter – August 2016

16 August 2016   In the arduous journey from explorative concept to development to commercial availability of the novel molecular entity – SCENESSE® afamelanotide 16mg)1 – one may become engrossed in the processes leading to the desired outcome. The ultimate goal of changing people’s lives is what drives us at Clinuvel and our team is […]

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Tuesday, 09 August 2016

Notice of Initial Substantial Holder

10 August 2016 Enclosed are the details of a notice of initial substantial holder. Download PDF for more

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Wednesday, 03 August 2016

Appendix 3Y

03 August 2016   We (the entity) give ASX the following information under listing rule 3.19A.2 and as agent for the director for the purposes of section 205G of the Corporations Act.    Download PDF for more

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Tuesday, 02 August 2016

Appendix 3B

02 August 2016   New issue announcement, application for quotation of additional securities and agreement   Download PDF for more

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02 August 2016   CLINUVEL prepares New Drug Application (NDA) for the treatment of erythropoietic protoporphyria (EPP) Executive summary: FDA requirement for combination therapy model replicating clinical studies protocol in vitiligo fulfilled Safety of the combination therapy confirms observations in clinical trials CUV102 and CUV103 CLINUVEL will request a guidance meeting with the FDA to […]

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Thursday, 28 July 2016

Appendix 4C – Q4 FY16

28 July 2016   Enclosed is a copy of the quarterly report for the period ending 30 June 2016   Download PDF for more

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17 July 2016   Clinuvel prepares New Drug Application (NDA) for the treatment of erythropoietic protoporphyria (EPP) Executive summary: FDA concludes initial review of datasets on SCENESSE® in EPP FDA deems datasets satisfactory for submission of New Drug Application Pre-NDA meeting with FDA to be scheduled to discuss timelines and procedure Clinuvel will request rolling […]

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05 July 2016   Executive summary: FDA awards Fast Track Designation¹ to expedite review of SCENESSE® in EPP NDA filing allowed on a rolling basis FDA hosting a Scientific Workshop² on EPP to learn more about disease and drug treatment Clinuvel Pharmaceuticals [ASX: CUV; Nasdaq International Designation ADR: CLVLY; Xetra-DAX: UR9] today announced that the […]

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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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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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