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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

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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) […]

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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 […]

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

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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 

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

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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

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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 […]

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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

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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 

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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 […]

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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 

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Wednesday, 16 May 2018

Change in substantial holding

Change in substantial holding Download attachments: 20180516Changeinsubstantialholding.pdf

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Monday, 14 May 2018

CLINUVEL REGULATORY UPDATE

14 May 2018   CLINUVEL PHARMACEUTICALS LTD  today provided an update on its global programs to facilitate access to treatment for patients with the ultra-rare genetic disorder erythropoietic protoporphyria (EPP): European Annual and Periodic Reports show positive benefit-risk and safety profile maintained SCENESSE® implants administered globally to date: >5,100 (>4,000 to EPP patients) >99% treatment compliance rate […]

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Tuesday, 01 May 2018

Change in substantial holding

01 May 2018   Enclosed is a notice of a change of interests of a substantial holder.   Download the PDF for more

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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 …

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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 …

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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 …

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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.

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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.

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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 …

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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 …

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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 …

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Wednesday, 29 January 2020

CLINUVEL Kommuniqué I

Sehr geehrte Aktionärinnen und Aktionäre, liebe FreundeIm 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, …

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Thursday, 16 January 2020

CLINUVEL Newsletter

Dear shareholders, friendsOn 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 …

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