Investor Area


Announcements by type

  • Presentation

  • Corporate

  • Newsletter

  • Regulatory

  • Financial

  • Clinical

  • Reset

Monday, 28 November 2016

Results of Meeting

28 November 2016 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 for more

Download PDF

27 November 2017   I would like to commence my address by saying it is always a pleasure to welcome familiar and a few new faces to the CLINUVEL Annual General Meeting. It has indeed been quite a journey since the early 2000’s, working in an environment of constant change requiring repeated changes of direction […]

Download PDF
Sunday, 27 November 2016

Managing Director’s AGM Presentation

27 November 2016   Good morning and welcome to CLINUVEL’s Annual General Meeting. The challenges ahead for 2017 are to reconcile the asymmetry in knowledge with regulators, governmental advisory bodies, payors, medical community and press on CLINUVEL’s innovative technology SCENESSE® (afamelanotide 16mg)1 and to differentiate CLINUVEL from other companies in our sector.   Download PDF […]

Download PDF

8 November 2016  CLINUVEL today announced that it met on 7 November with the US Food and Drug Administration’s (FDA’s) Division of Dermatology and Dental Products (DDDP) to discuss the content and format of a new drug application (NDA) submission as part of the US regulatory pathway for CLINUVEL’s medicinal product SCENESSE® (afamelanotide 16mg). The pharmaceutical […]

Download PDF
Monday, 31 October 2016

Response to Price Query

31 October 2016   Enclosed is CLINUVEL PHARMACEUTICALS LTD’s response to a price query lodged by the ASX.   Download PDF for more

Download PDF
Monday, 31 October 2016

Appendix 4C

31 October 2016   Enclosed is the quarterly report for the period ending 30 September 2016.   Download PDF for more

Download PDF
Wednesday, 26 October 2016

Notice of Annual General Meeting/Proxy Form

26 October 2016   This Explanatory Memorandum has been prepared for the Shareholders of the CLINUVEL PHARMACEUTICALS LIMITED ACN 089 644 119 in connection with the business to be conducted at the annual general meeting of Shareholders of the Company which will be held at: Location Karstens Conference Centres, 123 Queen Street, Melbourne, Victoria, Australia […]

Download PDF
Wednesday, 26 October 2016

Appendix 4G

26 October 2016   Enclosed is the Corporate Governance Council Principles and Recommendations as at 27 October 2016.    Download PDF for more

Download PDF
Saturday, 22 October 2016

CLINUVEL relocates Melbourne office

24 October 2016   CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY) today announced that its head office in Melbourne has relocated.   Download PDF for more

Download PDF

24 October 2016   The US Food and Drug Administration (FDA) will today host a scientific workshop on erythropoietic protoporphyria (EPP) at the FDA campus in Silver Spring. The workshop is open to all EPP stakeholders, with the FDA seeking perspective on EPP disease symptoms, its impact on daily life, experience with current treatment regimens […]

Download PDF
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 […]

Download PDF

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 […]

Download PDF

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 […]

Download PDF

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 […]

Download PDF
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 […]

Download PDF
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. [...]

Download PDF
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 …

Download PDF
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) …

Download PDF
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 …

Download PDF
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 …

Download PDF
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. …

Download PDF
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 …

Download PDF
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 …

Download PDF
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, …

Download PDF
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 …

Download PDF