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CLINUVEL INCLUDED IN S&P/ASX 200 INDEX 14 June 2019 Download PDF    

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6 June 2019   Download PDF

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Melbourne, Australia 5 June 2019 Download PDF

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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 CLINUVEL PHARMACEUTICALS LTD today published that the US Food and Drug Administration (FDA) Division of Dermatology and Dental Products (DDDP) has set a new Prescription Drug User Fee Act (PDUFA) goal […]

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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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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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Thursday, 10 January 2019

US FDA sets PDUFA date for SCENESSE®

Melbourne, Australia 10 January 2019 Priority Review granted for innovative drug, PDUFA date 8 July 2019  Executive summary New Drug Application submitted in accordance with section 505(b) of the Federal Food, Drug, and Cosmetic Act, filed in …

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Wednesday, 19 December 2018

CLINUVEL Vitiligo Communiqué

19 December 2018 As a depigmentation disorder (hypomelanosis), vitiligo is the most well-known of all leucodermatoses (“white skin”) whereby other variants of loss of skin pigmentation – temporary or permanent - are described as albinism, piebaldism, …

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Monday, 17 December 2018

CLINUVEL Newsletter - December 2018

17 December 2018 As the year draws to a close we look back at a hectic, yet successful, 12 months. In CLINUVEL’s marathon, the past year looked like a series of endless sprints to accomplish all we had …

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Monday, 05 November 2018

CLINUVEL Newsletter - November 2018

05 November 2018 The most recent quarterly financial results (1 July-30 September 2018) confirm the steady growth in clinical demand for SCENESSE® (afamelanotide 16mg) in erythropoietic protoporphyria (EPP), a rare genetic metabolic disorder.1 EPP is classified …

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Friday, 05 October 2018

Chair Letter to Shareholders

05 October 2018 This is a thank you to shareholders, investors, patients, clinicians, and all those who have continued to support CLINUVEL together with new shareholders who have recently gained confidence to join the CLINUVEL register. …

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