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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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19 February 2016   CLINUVEL Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced an update on the commercialisation of its novel drug SCENESSE® (afamelanotide 16mg) in adult patients with erythropoietic protoporphyria (EPP) in Europe. CLINUVEL has been working towards finalising distribution infrastructure, with a focus on a Risk Management Plan (RMP) and pharmacovigilance […]

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  10 February 2016   Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that its lead drug SCENESSE® (afamelanotide 16mg) has received an additional orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of cutaneous variants of porphyria. The ODD recognises the potential of afamelanotide to […]

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8 February 2016   Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA‐DAX: UR9; ADR: CLVLY) presented to an international porphyria  patient meeting, held in Rotterdam, the Netherlands, on February 6, 2016. The presentation and speaking notes are  appended to this announcement.   Download PDF for more

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Thursday, 28 January 2016

Appendix 4C – Q2 FY16

28 January 2016   Enclosed is a copy of the Quarterly report for entities admitted on the basis of commitments.     Download PDF for more

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Monday, 25 January 2016

Form 604

25 January 2016   Enclosed is a notice of a change of interest in substantial holder.   Download PDF for more

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Wednesday, 20 January 2016

CEO Brief – January 20, 2016

20 January 2016   Having both received and provided services within the healthcare sector over the years I am all too aware of the peril of compromised health and loss of your livelihood. In Clinuvel’s case we aspire to make our patients realise their dreams and ambitions by making SCENESSE® (afamelanotide 16mg) available to all […]

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Monday, 18 January 2016

Form 604

18 January 2016   Enclosed is a notice of change of interests of a substantial holder.    Download 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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