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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 […]

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15 May 2019   Download PDF

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Wednesday, 08 May 2019

Becoming a substantial holder

08 May 2019   Download PDF

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Thursday, 02 May 2019

CLINUVEL Newsletter

02 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 […]

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Tuesday, 30 April 2019

Appendix 4C

Melbourne, 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 […]

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Wednesday, 24 April 2019

Chair Letter to Shareholders

24 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 […]

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04 April 2019   Download PDF to view presentation

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Melbourne, 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 […]

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Wednesday, 20 March 2019

CLINUVEL Newsletter – March 2019

20 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 […]

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Friday, 15 March 2019

UK NICE Meeting Held

Melbourne, 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 […]

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Wednesday, 13 March 2019

Change in substantial holding

13 March 2019   Form 604Corporations Act 2001Section 671BNotice of change of interests of substantial holder   Download PDF to read more

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Wednesday, 13 March 2019

Change in substantial holding

13 March 2019   Form 604Corporations Act 2001Section 671BNotice of change of interests of substantial holder   Download PDF to read more

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13 March 2019   Change of Director’s Interest Notice   Download PDF to read more

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Wednesday, 13 March 2019

Appendix 3B

13 March 2019   New issue announcement, application for quotation of additional securities and agreement   Download PDF to read more

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Monday, 04 March 2019

Investor Briefing

4 March 2019 Investor Briefing – Non-Deal Roadshow Download PDF to read more

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  CLINUVEL 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 …

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Thursday, 17 October 2019

CLINUVEL Newsletter

  In 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 …

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Tuesday, 15 October 2019

Chair Letter to Shareholders

  Dear 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 …

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Tuesday, 20 August 2019

CLINUVEL Newsletter - August 2019

  Dear 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. [...]

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Thursday, 11 July 2019

CLINUVEL Newsletter - July 2019

  In 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 …

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Thursday, 02 May 2019

CLINUVEL Newsletter

02 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) …

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Wednesday, 24 April 2019

Chair Letter to Shareholders

24 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 …

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Wednesday, 20 March 2019

CLINUVEL Newsletter – March 2019

20 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 …

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Tuesday, 12 February 2019

CLINUVEL Vitiligo Communiqué II

12 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. …

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Tuesday, 15 January 2019

CLINUVEL Newsletter - January 2019

15 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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