Investor Area

News

Announcements by type

  • Presentation

  • Corporate

  • Newsletter

  • Regulatory

  • Financial

  • Clinical

  • Reset

 
Wednesday, 15 February 2017

CLINUVEL Newsletter – February 2017

16 February 2017   I wish all stakeholders of the CLINUVEL Group a healthy, mindful and successful 2017. After a Christmas break CLINUVEL started 2017 with fervour and ‘en bon esprit’. We look forward to an exciting year. During a meeting on 4 February in London international expert physicians, senior and paediatric patients, family carers […]

Download PDF
 
 
Tuesday, 31 January 2017

Appendix 4C – Quarterly report

31 January 2017   Enclosed is the quarterly report for the period ending 31 December 2016.   Download PDF for more

Download PDF
 
 
Thursday, 22 December 2016

Appendix 3Y

22 December 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

Download PDF
 
 
Tuesday, 20 December 2016

CLINUVEL Newsletter – December 2016

20 December 2016   At the end of a calendar year we look back on plenty of activities and a solid financial performance by the CLINUVEL Group. Our teams will break over the season’s holidays to reflect on a hectic year, but most of all to prepare ourselves physically and mentally for more exciting challenges […]

Download PDF
 
 
Monday, 12 December 2016

Appendix 3Y

12 December 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

Download PDF
 
 
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
 
Thursday, 23 July 2020

Kommuniqué IV

Liebe Aktionäre, Freunde,Es stellt sich eine neue Welt dar, die darauf hinweist, dass das Virus nicht so leicht zu beseitigen sein wird. Waehrend wir es akzeptieren, einen Modus der Koexistenz zu finden, muessen wir für …

Download PDF
 
Wednesday, 22 July 2020

CLINUVEL Newsletter

Communiqué IV, 2020 – 22 July 2020 Dear shareholders, friends,As a new world presents itself indicating that the virus will not easily be eliminated as we are accepting to find a modus co-existentiae, albeit we …

Download PDF
 
Thursday, 21 May 2020

Kommuniqué III

Liebe Aktionäre, Freunde,Die außergewöhnlichen Zeiten, in denen wir leben, haben alle Kontinente beeinflusst. Jedes verlorene Leben war eins zu viel. Ich kann unseren italienischen medizinischen Kollegen, Patienten und Familien, die mit der Tragödie kämpfen, nicht …

Download PDF
 
Tuesday, 19 May 2020

CLINUVEL Newsletter

Dear shareholders, friends,The extraordinary times in which we are living have affected all continents. Each life lost has been one too many. I cannot express enough empathy to our Italian medical colleagues, patients and families …

Download PDF
 
Friday, 08 May 2020

Chair Letter to Shareholders

Fellow shareholders,In my March letter I wished all good health during uncertain times. It is now clear the extent of damage COVID-19 has caused and will cause for many years in the future. I want …

Download PDF
 

Innovative drug launched for rare, isolating, “light intolerance” disorder Americans living with a rare genetic disorder that forces them to choose between self-isolation in the dark, or burning reactions from exposure to light, are welcoming an …

www.clinuvel.com

 

1 SCENESSE® (afamelanotide 16mg) is approved in the European Union as an orphan medicinal product for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). SCENESSE® is approved in the USA to increase pain free light exposure in adult EPP patients with a history of phototoxicity. Information on the product, including the approved prescribing information, can be found on CLINUVEL’s website at www.clinuvel.com.

2 Biolcati et al. (2015). Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyria. The British Journal of Dermatology. 172(6), 1601–1612. Langendonk et al. (2015). Afamelanotide for Erythropoietic Protoporphyria. The New England Journal of Medicine. 373(1), 48–59. Wensink et al. (2020). Association of Afamelanotide With Improved Outcomes in Patients With Erythropoietic Protoporphyria in Clinical Practice. JAMA Dermatology. EPub 18 March 2020.

Download PDF

 

CLINUVEL PHARMACEUTICALS LTD today announced that US insurance companies have agreed to reimburse SCENESSE® (afamelanotide) for patients diagnosed with erythropoietic protoporphyria (EPP).1SCENESSE® was approved by the US Food and Drug Administration (FDA) in October 2019 …

www.clinuvel.com.

2 Further details and terms and conditions are available from www.scenesse.com. This site is intended for US residents only.

Download PDF

 
Monday, 23 March 2020

CLINUVEL Kommuniqué II

Sehr geehrte Aktionäre, liebe Freunde,im Laufe des Jahres haben wir einen deutlichen Rückgang der globalen Aktienmärkte erlebt, der den Wertverlust von CLINUVEL noch verstärkt hat. Obwohl dies für viele unserer Aktionäre, einschließlich der Mitarbeiter, die …

Download PDF
 
Thursday, 19 March 2020

CLINUVEL Newsletter

Dear shareholders, friends,As the year unfolds, we have witnessed the significant downturn of global stock markets which has compounded the decline of CLINUVEL’s value. While regretful and painful for many of our shareholders, including staff …

Download PDF
 
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 …

Download PDF