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- 2012 Announcements
- Presentation: Clinical Study Results - US Phase IIa Vitiligo Study CUV102
- SCENESSE® successful in Phase IIa vitiligo study
- Appendix 3B & Lapse and Forfeit of Unlisted Conditional Performance Rights, Dec 2012
- Results of Meeting
- CEO's AGM Presentation
- Appendix 4C - quarterly (Q1 2012-13)
- Notice of Meeting and Proxy Form
- Observations from Clinuvel’s US vitiligo study published
- Appendix 3Z - Final Director's Interest Notice
- Clinuvel confirms date of Annual General Meeting
- Clinuvel expands its regulatory team while final European regulatory review of SCENESSE® is underway
- Dr Helmer Agersborg
- Appendix 4E - Preliminary Financial Report
- Appendix 4C - quarterly
- s.708A Notice
- Appendix 3Y
- Clinuvel Newsletter July 2012
- Appendix 3B
- Clinuvel Placement raises A$6.2 million
- Appendix 3B and Lapse of Unlisted Conditional Rights
- Clinuvel commences US Phase III trial of SCENESSE® in rare light and UV disorder
- Appendix 4C - quarterly
- Swiss insurers agree to reimburse Clinuvel’s SCENESSE® for rare disease
- Clinuvel Newsletter April 2012
- Clinuvel Corporate Update Presentation
- Appendix 3B
- Clinuvel, FDA agree in principle to Phase III study with SCENESSE® (afamelanotide)
- Observations from Clinuvel’s vitiligo and EPP programs being presented at the American Academy of Dermatology
- Clinuvel Newsletter February 2012
- Appendix 4D - Half Yearly Report
- Lapse and Forfeit of Unlisted Share options
- Clinuvel files European marketing authorisation application for SCENESSE® (afamelanotide)
- Appendix 4C - quarterly
- Appendix 3B
- Response to Price Query
- Appendix 3B
- 2011 Announcements
- Letter from the CEO
- Clinuvel announces positive results from pivotal European Phase III study: endpoints demonstrate clinically relevant treatment effect of afamelanotide
- Encouraging interim safety results of SCENESSE® in Phase II study in organ transplant recipients (OTRs)
- Appendix 3B
- Change of Director's Interest Notice x 4
- Appendix 3B & Lapse and Forfeit of Unlisted Conditional Performance Rights
- Clinuvel Newsletter May 2011
- Results of Meeting
- CEO's AGM Presentation
- Clinuvel granted US topical formulation patent
- Clinuvel demonstrates positive treatment effect of afamelanotide in US Phase II study
- Media release: Clinuvel announces positive results of first Phase II US study of SCENESSE® in orphan disease erythropoietic protoporphyria (EPP)
- Amendment to Change of Director's Interest Notice
- First positive observations from Clinuvel’s US vitiligo trial
- Appendix 4C - quarterly
- Clinuvel Newsletter October 2011
- Notice of Meeting and Proxy Form
- Clinuvel confirms date of Annual General Meeting
- Change of Director's Interest Notice
- Appendix 3B
- Clinuvel completes pre-clinical program for SCENESSE® (afamelanotide)
- Appendix 4E - Preliminary Final Report
- Lapse and Forfeit of Unlisted Share Options & Conditional Performance Rights
- Letter to Shareholders
- Appendix 4C - quarterly
- Clinuvel Corporate Update Presentation
- Clinuvel records first A$1 million in sales
- Clinuvel investor update presentation
- Clinuvel granted Australian formulation patent
- EMA acknowledges Clinuvel filing afamelanotide in Europe in 2011
- Clinuvel Relocates Melbourne Office
- Clinuvel books European Pre-Submission Meeting for SCENESSE® marketing authorisation application (MAA)
- Appendix 4C - quarterly
- Letter from the Chairman
- SCENESSE® (afamelanotide) data to be presented at global porphyria conference
- Response to an ASX Price Query
- Appendix 3B & Lapse and Forfeit of Unlisted Conditional Performance Rights
- FDA allows Clinuvel’s innovative vitiligo trial
- Clinuvel’s vitiligo program – trial participation
- FDA allows world first vitiligo drug trial
- Appendix 4D - Half Yearly Report
- Initial Director's Interest Notice
- Clinuvel completes first Phase II US study
- Clinuvel appoints new Non-Executive Director
- Appendix 4C
- Clinuvel hosts 3rd Annual Scientific & Clinical Excellence Meeting (ASCEM III)
- Letter to shareholders
- 2010 Announcements
- Clinuvel Share Trading Policy
- Appendix 3B
- Amendment to Appendix 3Y
- Letter from the CEO
- Appendix 3Y
- Appendix 3B
- Clinuvel completes share consolidation
- TGA grants Orphan Drug Designation for SCENESSE®
- Approval to Consolidate Share Capital on 10:1 ratio
- Clinuvel AGM 2010 CEO Presentation
- Results of Meeting
- FDA provides positive guidance on Clinuvel's EPP program
- Appendix 4C
- Annual Report 2010
- Notice of Meeting and Proxy Form
- Clinuvel confirms date of Annual General Meeting
- Final Director’s Interest Notice
- Clinuvel Strategic Update
- Resignation of Non-Executive Director
- Appendix 3B & Lapse and Forfeit of Unlisted Conditional Performance Rights
- Appendix 4E Preliminary final report
- UV-protective drug to be tested for vitiligo
- Clinuvel to evaluate SCENESSE® as therapy in vitiligo
- Appendix 3B
- Appendix 4C - quarterly
- Webcast transcript: Clinuvel CEO Dr Philippe Wolgen discusses results from the CUV017 trial
- Successful drug trial results for light intolerant 'shadow jumpers'
- Clinuvel reports positive results in Phase III porphyria (EPP) clinical trial
- Novel UV protecting drug delivered by the picogram
- Clinuvel selects leading US manufacturing partner for SCENESSE®
- Letter from the CEO
- US patent to assist drug as potential skin cancer preventative in redheads
- US patent for alpha-MSH and analogues for use in UV protection
- Structural changes in preparation for commercial phase
- Form 605
- Clinuvel unveils SCENESSE® following European brand approval
- Italian Medicines Agency (AIFA) provides reimbursement for the treatment of EPP with afamelanotide
- Italian patients request UV-drug: afamelanotide available for rare sun disorder
- Lapse of Unlisted Share Options
- Appendix 3B
- Corporate Presentation - March 2010
- Appendix 4C
- FDA allows US clinical trials of afamelanotide in EPP
- Lapse of Unlisted Share Options
- 2009 Announcements
- Clinuvel announces positive Phase III interim results for EPP
- Media Release: Clinuvel: positive interim Phase III results for unique skin protection drug
- Open Briefing. Clinuvel. FDA grants IND status
- FDA allows IND status for Clinuvel's afamelanotide
- Media Release: FDA allows IND status for Clinuvel's afamelanotide
- Appendix 4C
- Clinuvel Corporate Presentation - March 2009
- Open Briefing. Clinuvel. Revenue Prospects and Strategy
- Response to an ASX Price Query
- Appendix 4C
- May 2009 European Roadshow Presentation
- EMEA grants Clinuvel new orphan drug designation
- Lapse and Expiry of Unlisted Share Options
- Clinuvel announces positive results in Phase II Solar Urticaria study
- Technical Note: Phase II Solar Urticaria study
- Appendix 4C
- Appendix 3Y
- Clinuvel Afamelanotide Commercialisation Presentation - August 2009
- Open Briefing. Clinuvel. CEO on afamelanotide commercialisation.
- Preliminary final report
- Confirmatory Phase III EPP trial receives approval.
- CEO Presentation - Rodman and Renshaw Healthcare Conference.
- Financial Report Year Ended 30 June 2009
- Conditional Performance Rights Plan
- Notice of Meeting and Proxy Form
- Annual Report to shareholders
- Appendix 3B
- Appendix 4C
- Expiry of Unlisted Share Options
- Open Briefing. Clinuvel. CEO on MAA application to EMEA
- Clinuvel AGM 2009 Chair and CEO Presentation
- Results of Meeting
- Appendix 3Y
- The European Medicines Agency grants Clinuvel SME status
- Afamelanotide improved quality of life in cancer patients
- Media Release: Drug improves quality of life in cancer patients
- Clinuvel announces PLE Phase III preliminary results
- 2008 Announcements
- Response to price query
- Appendix 4C
- Appendix 3B
- Appendix 4D Half Yearly Report
- EMEA grants Clinuvel two orphan drug designations
- Corporate Briefing on Orphan Medicinal Product Designations
- Clinuvel Investor Update via teleconference
- Teleconference transcript of Investor Update held 19 March 2008
- Update Investor Presentation April 2008
- Clinuvel's latest pharmacokinetic studies further validate human safety of CUV1647
- Swissmedic grants Clinuvel Orphan Drug Status for CUV1647
- Appendix 4C
- Clinuvel receives approval to begin Phase II Trials in Solar Urticaria
- Corporate Presentation - FINSIA Lifesciences Showcase
- World Health Organisation Assigns CUV1647 Generic Name
- Appendix 3B
- New Non-Executive Director
- Appendix 3X - Initial Director's Interest Notice
- Open Briefing. Clinuvel. Strategy & Clinical Program Update
- FDA grants Clinuvel orphan-drug designation
- Appendix 4C
- Open Briefing. Clinuvel. FDA Orphan Drug Designation Approval
- Appendix 4E
- International and Australian investors buyout substantial shareholder
- Ceasing to be a substantial holder (ASX online)
- Ceasing to be a substantial holder (ASX online)
- Becoming a substantial holder (ASX online)
- Amended Becoming a substantial holder notice (ASX online)
- Clinuvel commences Phase II trial in Photodynamic Therapy
- Financial Report Year Ended 30 June 2008
- Notice of Meeting and Proxy form
- Appendix 4C
- 2008 AGM Results of Meeting
- 2008 CSO AGM Presentation
- 2008 CEO AGM Presentation
- Appendix 3B
- Appendix 3Y
- Clinuvel lodges IND in US
- Open Briefing. Clinuvel. Submission of IND Application
- 2007 Announcements
- Open Briefing Clinuvel CEO on Commercialisation Goals
- Clinuvel Pharmaceuticals Ltd appoints new Chair
- Teleconference transcript of Investor Update held 22 November 2007
- Clinuvel's second regular investor update via teleconference
- Clinuvel opens Europe office
- AGM 2007 Results of Meeting
- Clinuvel AGM Presentation
- Clinuvel’s drug begins global Phase II skin cancer trials
- Appendix 4C
- AGM Notice of Meeting
- Open Briefing 2 October 2007
- Financial Report Year Ended 30 June 2007
- Clinuvel Shareholder Update 19 September 2007 Conference Call
- Conference Call and Weblink
- Shareholder Update Repeat Conference Call
- Shareholder Update
- Clinuvel initiates regular investor update via teleconference – Updated contact numbers
- Appendix 3Y
- Amendment to Appendix 4E
- Appendix 4E and Preliminary Financial Report
- Clinuvel Appoints Head of Corporate Development
- Appendix 3B
- Appendix 4C
- Selection of final dosage for development of CUV1647
- Dr Aston appointed to Goverment Committee
- Clinuvel relocates Melbourne office
- Open Briefing®. Clinuvel. Update on Start of Phase III
- Appendix 3Z - Final Director’s Interest Notice
- Appendix 3B - Application for Quotation of Additional Securities
- Phase III trial begins in Erythropoietic Protoporphyria
- Clinuvel Share Purchase Plan completed
- Clinuvel board member resigns
- Phase III trial of CUV1647 begins in Polymorphic Light Eruption
- Clinuvel Share Purchase Plan
- Correction to Appendix 3B – Application for Quotation of Additional Securities
- Appendix 3B - Application for Quotation of Additional Securities
- Appendix 4C March 2007 Quarterly Report
- Clinuvel Completes A$26M Private Placement
- Request for Trading Halt
- Clinuvel receives approval to begin Phase III trials in EPP
- Strategic Update to Investors
- Open Briefing. Clinuvel. CUV1647 Treatment of PDT
- New Oncology application identified for CUV1647
- Appendix 4D Half Year Report
- Open Briefing Clinuvel Phase III PLE Trials
- Appendix 4C December 2006 Quarterly Report
- EGM Results
- Appendix 3B
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- What can vitiligo patients do? – Lee Thomas and Dr Philippe Wolgen, Part 4
- The future of vitiligo treatment – Lee Thomas and Dr Philippe Wolgen, Part 3
- Vitiligo trials of SCENESSE® – Lee Thomas and Dr Philippe Wolgen, Part 2
- SCENESSE® and its use in vitiligo – Lee Thomas and Dr Philippe Wolgen, Part 1
- Liver transplantation in erythropoietic protoporphyria (EPP)
- Understanding Vitiligo: Misconception & Myth
- 'Check up' reports on rare disease EPP and SCENESSE® (afamelanotide)
- "Focus really pays off in the end"
- Part Four - The impact of Erythropoietic Protoporphyria (EPP) on life
- What is my skin type? (the six Fitzpatrick skin types)
- What is skin? The layers of human skin
- Quick! I need Sunburn Relief! Remedies and treatment for sunburn.
- Understanding Vitiligo - Causes & Theories April 2011
- Part Three - Burning in shadows
- Increasing Ultraviolet Levels
- Part Two - "People don't believe what they can't see"
- Vitiligo and Stem Cells: Narrowband UVB Phototherapy
- Part one - "Absolute intolerance to light"
- Vitiligo: a breakthrough therapy
- אי.פי.פ
- "Ein Leben im Schatten"
- Clinuvel CEO discusses positive phase III results
- A life in the shadow
- "GMP, setting standards around the world"
- Clinuvel's manufacturing partner for SCENESSE®
- „Die Angst vor dem was da noch kommen mag“
- פרוטופורפיריה אריתרופויטית (אי.פי.פי) היא מחלה גנטית קשה.
- "נתק את עצמך מהכאב"
- „Man distanziert sich sozusagen vom Schmerz“
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- Light & UV In Australia
- Final year of filing MAA
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- "the golden age?"
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- Absolute light intolerance: Erythropoietic protoporphyria (EPP)
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- JAMA features vitiligo study as cover story
- Clinuvel completes first vitiligo study
- Clinuvel commences US Phase III trial of SCENESSE® in EPP
- Clinuvel files European MAA for SCENESSE® (afamelanotide)
- Updated: Clinuvel announces EU Phase III EPP results
- Q4 2011 media
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- 2013 Announcements
- s.708A Notice, May 2013
- Appendix 3B & Lapse and Forfeit of Unlisted Conditional Performance Rights, May 2013
- Clinuvel Placement completed successfully
- Suspension from official quotation
- Request for voluntary suspension
- Trading Halt
- Trading Halt Request
- Appendix 4C - quarterly (Q3 2012-13)
- Clinuvel Newsletter - April 2013
- Clinuvel expects EMA outcome in second half of 2013
- Appendix 3B & Lapse and Forfeit of Unlisted Conditional Performance Rights, March 2013
- SCENESSE® data to be presented at American Academy of Dermatology, San Gallicano Rare Disease conferences
- Clinuvel clears EMA manufacturing audit
- Appendix 4D
- Appendix 3Y - Feb 2013
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- Appendix 4C - quarterly (Q2 2012-13)
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- Clinuvel Newsletter - February 2013
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- Annual Report for the year ended 30 June 2012
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- Analyst Reports
- Nomura update "Funds to be used for further clinical development"
- Nomura Quick Note: "Delay for European EPP decision"
- Nomura update "We believe the EMA decision is due in the short-term"
- Nomura update "Statistically significant results – will progress to a Phase IIb"
- Nomura Quick Note: "Vitiligo journal article released"
- Nomura Update "F12 – good progress, expect a F13 EMA decision"
- Nomura Update "Funds to be used for further clinical development"
- Nomura Quick Note: "Launches US Phase III trial for EPP treatment"
- Nomura Quick Note: "Afamelanotide receives approval in Switzerland"
- Nomura Update "Considerable upside should NSV trials be successful"
- Nomura Quick Note: "Vitiligo and EPP opportunities progress"
- Nomura Update "We believe the Vitiligo market is currently underserved"
- Nomura Quick Note: "MAA review should complete by start 4QCY12"
- Edison QuickView: Positive in Phase III
- Nomura Quick Note: "Positive result from pivotal EU Phase III study"
- Nomura Update "CUV's statistically significant EPP results"
- Nomura Update "Vitiligo - addressing a large unmet need"
- Nomura Update "FY11 - looking to enter the Vitiligo market"
- Nomura Update "1H FY11 – waiting for the sun"
- NOMURA Analyst Report
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- Tolhurst Noall - update
- Tolhurst Noall - update
- Tolhurst Noall - initiation of coverage
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- RBS - "US biogeneric exclusivity extended"
- RBS Update: Clinuvel Continues to confirm potential
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- RBS Update "Interim Phase III results revealed"
- RBS Update "Analysis of CUV's opportunities"
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Clinuvel Blog Posts
Today, February 28, marks Rare Disease Day: an annual event to help highlight the effects of rare diseases on individuals, families and the...
Read MoreWe've just released the first results from our vitiligo program which you can view online here. Following their release, we expect a number...
Read More
I find vitiligo to be a fascinating, yet devastating disorder: almost overnight, patients see their skin colour erode and their identity...
Read MoreClinuvel Webcasts
Taking on Vitiligo, a depigmentation disorder of the skin. In 2010, Clinuvel ventured into an area of dermatology where no other pharmaceut... Watch now |
Taking on Vitiligo, a depigmentation disorder of the skin. In 2010, Clinuvel ventured into an area of dermatology where no other pharmaceut... Watch now |
Taking on Vitiligo, a depigmentation disorder of the skin. In 2010, Clinuvel ventured into an area of dermatology where no other pharmaceut... Watch now |
Clinuvel Spotlight
The technology behind Clinuvel’s lead drug, SCENESSE® (afamelanotide), has been in research and development since the 1980s when a small team of scientists set out to investigate methods of preventing skin cancer in humans. Clinuvel licensed this technology and has spent over A$20million optimising the chemistry of afamelanotide (the active ingredient in SCENESSE®) an... Read more |









