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CLINUVEL PHARMACEUTICALS LTD wishes to advise in accordance with the terms and conditions of issue that the following unquoted performance rights have lapsed and forfeited: Class Number Exercise price CUVAK Conditional Performance Rights subject to various performance milestones, issued various dates 40,000 $Nil Consequently, there are now 1,666,460 unlisted conditional performance rights on issue. Download […]
Download PDFAppendix 3Y Change of Director’s Interest Notice Download PDF
Download PDFNew issue announcement, application for quotation of additional securities and agreement. Download PDF
Download PDFCLINUVEL PHARMACEUTICALS LTD today announced changes to the composition of its Audit & Risk Committee and to its Remuneration Committee. Consequent to his retirement from the Board of Directors, Stan McLiesh will be replaced by Jeffrey Rosenfeld on the Audit & Risk Committee as a voting member. Sue Smith and Karen Agersborg will join […]
Download PDFDear shareholders, On 8 October 2019, CLINUVEL obtained its first and historic US Food and Drug Administration (FDA) approval, some 39 years since the afamelanotide technology was first discovered in a university laboratory. On this day the intraday share price went up briefly to A$45.88, valuing the Company at A$2.2B; we have seen sell offs […]
Download PDFCLINUVEL PHARMACEUTICALS LTD today announced the appointment of Professor Jeffrey Rosenfeld as a Non-Executive member of the Group’s Board of Directors. Download PDF
Download PDFMelbourne, Australia, 20 November 2019 A MOMENTOUS ACHIEVEMENT Looking at the year in retrospect, I draw a balance on the overall resources it took to achieve one of the greatest successes in Australian pharmaceutical history. At a relatively low expense of under A$139 million, we arrived at a commercial product to serve the needs of […]
Download PDFResults of Annual General Meeting 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
Download PDFMelbourne, Australia, 20 November 2019 “We are here today to reflect on a memorable moment, exactly 42 days after the historic FDA approval of SCENESSE® (afamelanotide 16mg), a first for Australia as a New Chemical Entity has come from preclinical stage to market. It marks exactly 39 years since the technology was discovered and first […]
Download PDFCLINUVEL PHARMACEUTICALS LTD, 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 July to 30 September 2019. Download PDF
Download PDFCLINUVEL PHARMACEUTICALS LTD today announced that the Australian Therapeutic Goods Administration (TGA) has granted SCENESSE® (afamelanotide 16 mg) the right to be filed under the priority registration process. This establishes a target scientific evaluation timeframe of 150 working days, calculated from the first day the scientific dossier is accepted. SCENESSE® will be lodged for the […]
Download PDFDearest Shareholders, As the incoming Chair of the Company, in short letters I will try to provide you with updates and inform you about our business.[…] Download PDF
Download PDFCLINUVEL PHARMACEUTICALS LTD today announced that Mr Stan McLiesh will retire from his role as Non-Executive Director and Chair of the Board on 30 November 2019. Non-Executive Director Mr Willem Blijdorp has been elected Chair and will take on the role on 30 November 2019. […] Download PDF
Download PDFCLINUVEL PHARMACEUTICALS Corporate Governance Statement has been updated and is available to download. Download PDF
Download PDFLiebe 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 PDFDear 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 PDFFellow 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 PDFInnovative 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 …
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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.
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.
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 PDFDear 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 PDFFellow 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 PDFSehr 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, …
Download PDFDear 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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