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20 June 2016   First commercial delivery, SCENESSE® approved as standard of care in the Netherlands. CLINUVEL Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that its drug SCENESSE® (afamelanotide 16mg) has been launched in Europe, with the first commercial delivery of the product under European marketing authorisation. Patients with the rare genetic disorder […]

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 31 May 2016   CLINUVEL Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced the inclusion of its Sponsored Level 1 American Depository Receipt (ADR) program in Nasdaq’s International Designation, a new visibility offering available to non-US companies. CLINUVEL is the first life science company to be selected for this initiative, first launched by […]

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Tuesday, 17 May 2016

SCENESSE® treatment in Europe

17 May 2016   German Porphyria Expert Centres to start distribution of SCENESSE® (afamelanotide 16mg) Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced an update on the company’s post-authorisation distribution of SCENESSE® (afamelanotide 16mg) across Europe for adult patients with the rare disorder erythropoietic protoporphyria (EPP).   Download PDF for more

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Friday, 29 April 2016

Appendix 4C – Q3 FY16

29 April 2016   Enclosed is a copy of the quarterly report for the period ending 31 March 2016.   Download PDF for more

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Monday, 11 April 2016

Form 604

11 April 2016   Enclosed is a notice of change of interests of substantial holder   Download PDF for more

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Monday, 04 April 2016

CLINUVEL Newsletter – April 2016

4 April 2016   Clinuvel is arriving at a point many of our patients and investors have longed for: first commercial treatment for EPP patients. Last month our European teams conducted a number of training and accreditation visits at European Hospitals. The purpose of these site visits was to instruct staff, management and clinical personnel […]

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23 March 2016   NICE’s technical team invited stakeholders with an interest in the treatment of erythropoietic protoporphyria (EPP) Executive summary SCENESSE® evaluated as part of the Highly Specialised Technologies Programme (HST) in UK HST Programme review of relatively high cost – low volume technology Evaluation of the drug as an innovative therapy for unmet […]

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Friday, 18 March 2016

s.708A Notice

18 March 2016   Notice under section 708A(5)(e) of the Corporations Act 2001   Download PDF for more

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Friday, 18 March 2016

Appendix 3B

18 March 2016   Enclosed is a new issue announcement, application for quotation of additional securities and agreement   Download PDF for more

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Friday, 18 March 2016

Form 604

18 March 2016   Enclosed is a Notice of Change of Interests of Substantial Holder.   Download PDF for more

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Tuesday, 15 March 2016

Form 604 – March 15, 2016

15 March 2016   Enclosed is a notice of a change of interest of substantial holder.   Download PDF for more

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 13 March 2016   CLINUVEL Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that its European commercial team is conducting site training and accreditation at the first of the European expert porphyria centres this week. Following training these centres of expertise will be accredited to prescribe CLINUVEL’s drug SCENESSE® (afamelanotide 16mg) to adult […]

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13 March 2016   ** Not for release or distribution in the United States ** CLINUVEL Pharmaceuticals Limited has successfully raised A$8.3 million dollars via a private placement (“Placement”) to existing and new international institutional and professional investors.   Download PDF for more

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Friday, 11 March 2016

Request for Trading Halt

11 March 2016   Pursuant to Listing Rule 17.1, Clinuvel Pharmaceuticals Ltd (CUV) requests a trading halt with respect to its ordinary shares from the commencement of trading on Friday 11th March 2016 until the commencement of trading Tuesday 15th March, 2016.   Download PDF for more

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Friday, 19 February 2016

Appendix 4D and Half Year Report

19 February 2016   Your Directors present their report on the company and its controlled entities for the half year ended 31 December 2015.   Download PDF for more

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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 …

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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 …

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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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