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Melbourne, Australia 3 June 2019 Download PDF The FDA sets new goal date of 6 October 2019 to complete review and issue risk-benefit decision Executive summary New PDUFA goal date set for 6 October 2019 New timeline to communicate labelling changes and post-marketing commitments by 6 September 2019 Scientific exchange between FDA and CLINUVEL […]
Download PDF02 May 2019 Download PDF Dear patients, shareholders, friends, In this Communiqué we concentrate on CLINUVEL’s programs and US market access for SCENESSE®. As the European season unfolds, we report on the back of quarterly financials (released 30 April) which are on track against our own projections. Importantly, our commercial teams and finance staff […]
Download PDFMelbourne, Australia, 30 April 2019 Download PDF CLINUVEL 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 January to 31 March 2019. All figures are rounded and […]
Download PDF24 April 2019 Download PDF Dear All, On a continent where very few biotechnology and pharmaceutical companies have ever succeeded in taking a first-in-class and first-in-line therapy from concept to commercialisation, CLINUVEL has all the makings of becoming a lasting success story in Australian life sciences. It will become a Company serving many […]
Download PDF04 April 2019 Download PDF to view presentation
Download PDFMelbourne, Australia and Leatherhead, UK, 29 March 2019 Download PDF to read more CLINUVEL PHARMACEUTICALS LTD today announced that it will host national expert meetings in Berlin, Germany, on 29 March and Florence, Italy, on 5 April to evaluate the treatment of erythropoietic protoporphyria (EPP). Clinicians and medical staff from a number of EPP expert […]
Download PDF20 March 2019 Download PDF Dear patients, shareholders, friends,In the third Communiqué we are reviewing our EU operations, the impact of Brexit and looking at the year ahead. FDA REVIEW At the time of print CLINUVEL will find itself within four months of the US Prescription Drug User Fee Act (PDUFA) date, while […]
Download PDFMelbourne, Australia, 15 March 2019 Third meeting of Highly Specialised Technology Committee CLINUVEL PHARMACEUTICALS LTD announced that it had met with the Highly Specialised Technology (HST) Committee of the English National Institute of Health and Care Excellence (NICE) in Manchester on 14 March (Greenwich Mean Time) as part of the ongoing evaluation of CLINUVEL’s drug […]
Download PDF13 March 2019 Form 604Corporations Act 2001Section 671BNotice of change of interests of substantial holder Download PDF to read more
Download PDF13 March 2019 Form 604Corporations Act 2001Section 671BNotice of change of interests of substantial holder Download PDF to read more
Download PDF13 March 2019 Change of Director’s Interest Notice Download PDF to read more
Download PDF13 March 2019 New issue announcement, application for quotation of additional securities and agreement Download PDF to read more
Download PDF4 March 2019 Investor Briefing – Non-Deal Roadshow Download PDF to read more
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 …
Download PDFIn this News Communiqué VII, we pause to reflect on the outstanding US regulatory outcome and look back one last time at all the events which led to the long-desired outcome on 8 October, the …
Download PDFDear All, In my career in life sciences, I have served on public Boards, was part of the management team that led CSL to its position and oversaw several executive transitions in our beloved Company, first …
Download PDFDear patients, shareholders, friends, In this News Communiqué VI for the year we report further on CLINUVEL’s regulatory progress in the US and the latest quarterly results for the period ending 30 June 2019. [...]
Download PDFIn this Communiqué we turn our attention to the most recent news communicated to the Company on 31 May by the US Food and Drug Administration (FDA): an extension of the scientific review time for …
Download PDF02 May 2019 Dear patients, shareholders, friends,In this Communiqué we concentrate on CLINUVEL’s programs and US market access for SCENESSE®.As the European season unfolds, we report on the back of quarterly financials (released 30 April) …
Download PDF24 April 2019 Dear All,On a continent where very few biotechnology and pharmaceutical companies have ever succeeded in taking a first-in-class and first-in-line therapy from concept to commercialisation, CLINUVEL has all the makings of becoming …
Download PDF20 March 2019 Dear patients, shareholders, friends,In the third Communiqué we are reviewing our EU operations, the impact of Brexit and looking at the year ahead. FDA REVIEWAt the time of print CLINUVEL will find itself …
Download PDF12 February 2019 In the second Communiqué we look closer at the role of narrowband UVB (NB-UVB) as the only standard of care at present in vitiligo, both the segmental and generalised form of the disease. …
Download PDF15 January 2019 Dear patients, shareholders, friends,I wish you all a year in good physical and spiritual health, and a year in which we anticipate further progress of SCENESSE ® (afamelanotide 16mg)1 and CLINUVEL’s other products …
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