Investor Area

News

Announcements by type

  • Presentation

  • Corporate

  • Newsletter

  • Regulatory

  • Financial

  • Clinical

  • Reset

 
Wednesday, 29 August 2018

Notification of dividend / distribution

Download attachments: Download PDF

Download PDF
 
 
Wednesday, 29 August 2018

CLINUVEL declares first time dividend

29 August 2018   CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) is pleased to announce that it will issue a dividend for the first time in its history for the 12-month financial reporting period ended 30 June 2018. Subject to the Company maintaining sufficient reserves, the Board of Directors have agreed […]

Download PDF
 
 

29 August 2018   The Directors of the Board present their report on the Company and its controlled entities (‘Group’) for the financial year ended 30 June 2018 and the Auditor’s Independence Declaration thereon.   Download PDF to read more

Download PDF
 
 
Tuesday, 21 August 2018

CLINUVEL Investor Summary

21 August 2018   Increasing interest has been seen in the interaction between the human body and non-ionising radiation, part of the emerging field of photomedicine. During the latter decades of the last century the scientific community first began to grasp the short- and long-term impacts of acute and chronic exposure to invisible ultraviolet (UV) […]

Download PDF
 
 
Monday, 30 July 2018

Appendix 4C

30 July 2018   CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY), 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 April to 30 June 2018. All […]

Download PDF
 
 
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 has been imperative for our teams to thoroughly prepare the scientific write-up and analyses of the use of […]

Download PDF
 
 
Tuesday, 17 July 2018

Change in substantial holding

17 July 2018 Enclosed is a notice of a change of interest of a  substantial shareholder. Download PDF for more 

Download PDF
 
 

6 July 2018   Enclosed is a change in director’s interest notice.    Download PDF for more

Download PDF
 
 
Wednesday, 04 July 2018

Change in substantial holding

04 July 2018   Enclosed is a notice of a change in substantial holding of a shareholder.   Download PDF for more

Download PDF
 
 

25 June 2018   EXECUTIVE SUMMARY First NDA for SCENESSE® (afamelanotide 16mg) in the United States First-line therapy proposed as systemic photoprotection for EPP patients Submission of data from five clinical trials in EPP, pooled data, Compassionate Use, Special Access Schemes, and real-world experience from European use Nearly 6,700 afamelanotide doses administered to more than […]

Download PDF
 
 
Friday, 22 June 2018

Trading Halt

22 June 2018   Pursuant to Listing Rule 17.1, Clinuvel Pharmaceuticals Ltd (CUV) requests an immediate trading halt with respect to its ordinary shares listed on the ASX.   Download PDF for more

Download PDF
 
 
Friday, 01 June 2018

Appendix 3B

01 June 2018   Enclosed is a new issue announcement regarding an application for quotation of additional securities and agreement.   Download PDF for more 

Download PDF
 
 

23 May 2018   CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) today announced that the English National Institute of Health and Care Excellence (NICE) maintained its position not to recommend CLINUVEL’s drug SCENESSE® (afamelanotide 16mg) for reimbursement in England (see ASX announcement 21 December 2017). In its evaluation of novel medicinal […]

Download PDF
 
 
Thursday, 17 May 2018

Change in substantial holding

17 May 2018   Enclosed is a notice of a change in substantial holding of a shareholder   Download PDF for more 

Download PDF
 
 
Wednesday, 16 May 2018

Change in substantial holding

Change in substantial holding Download attachments: 20180516Changeinsubstantialholding.pdf

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