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CLINUVEL's company releases, including archives.

Thursday, 27 August 2015 17:32

FDA grants Clinuvel a Type C Meeting

Discussion on US pathway to marketing approval for SCENESSE® Clinuvel Pharmaceuticals Limited (ASX: CUV; ADR:CLVLY; XETRA:DAX) today announced that it will meet the US Food and Drug Administration (FDA) to discuss the overall development of SCENESSE® (afamelanotide 16 mg) and the filing requirements for a New Drug Application (NDA) for the treatment of adult patients diagnosed with erythropoietic protoporphyria (EPP; absolute light intolerance).BACKGROUNDClinuvel has been in regular dialogue with the FDA throughout the SCENESSE® development program. The FDA’s Office for Orphan Products Development designated SCENESSE® as an orphan drug for EPP in 2008. Orphan drug designation recognises the potential of…
Wednesday, 23 September 2015 17:48

Form 603 - September 23, 2015

Monday, 21 September 2015 16:03

SCENESSE® released for European Distribution

Pharmacovigilance Risk Assessment Committee reviews Post Authorisation Safety Study [PASS] Clinuvel Pharmaceuticals Limited (ASX: CUV; ADR:CLVLY; XETRA:DAX) announces today that the European Medicines Agency’s (EMA’s) Pharmacovigilance and Risk Committee (PRAC) has agreed to a Post Authorisation Safety Study (PASS) protocol, allowing SCENESSE® (afamelanotide 16mg) to be released for the commercial supply to adult patients diagnosed with erythropoietic protoporphyria (EPP). While SCENESSE® was granted European marketing authorisation by the European Commission on 22 December 2014, it has taken a further nine months to gain agreement on the proposed PASS protocol.PHARMACOVIGILANCEAs part of the marketing authorisation, Clinuvel and the EMA agreed upon…
Friday, 31 July 2015 15:55

Appendix 4C - Q4 FY15

Thursday, 30 July 2015 18:14

Form 605 - July 30 2015

Wednesday, 15 July 2015 17:12

Clinuvel Newsletter - July 2015

Breakthrough treatment for orphan genetic disorder presented to the general medical community EXECUTIVE SUMMARY SCENESSE® published as innovative treatment in erythropoietic protoporphyria (EPP) Combined analyses of Phase III studies show significant improvement in the duration of patient sun exposure without phototoxicity New England Journal of Medicine: highest “impact factor” medical journal Pivotal studies led to December 2014 European marketing authorisation Melbourne, Australia and Leatherhead, UK Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that results from its pivotal Phase III studies of SCENESSE® (afamelanotide 16mg) in the orphan genetic disorder erythropoietic protoporphyria (EPP) have been published in…
Friday, 05 June 2015 13:50

SCENESSE® Commercialisation Update

SUMMARY SCENESSE® Risk Management Plan infrastructure nearing finalisation EPP expert centre training commences this week Leatherhead, UK and Melbourne, Australia Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced an update on the commercial distribution of its drug SCENESSE® (afamelanotide 16mg) for erythropoietic protoporphyria (EPP) across Europe. SCENESSE® was granted marketing authorisation by the European Commission for adults diagnosed with EPP on December 22, 2014. A number of post-authorisation commitments were agreed with the European Medicines Agency (EMA) under a long-term risk management plan (RMP) for SCENESSE®. The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is scheduled to complete…
Friday, 15 May 2015 14:00

Media Coverage

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To receive regular updates, including all of CLINUVEL's announcements, you can subscribe to our email database here. A selection of press coverage is listed below Title Link Aus dem Schatten hervortreten NZZ Exposure to sunlight burns my skin – now I can come out the shadows thanks to new drug Bournemouth Echo INTERVIEW: CLINUVEL's Philippe Wolgen on Scenesse and the patient factor Scrip CLINUVEL's subisidiary develops drug candidate for vitiligo Biospectrum Asia Wanneer de zon een hel wordt VTM News Out of the shadows (content only available in the USA) NBC Dateline 11-Year-Old 'Allergic' to Sunlight Good Morning America Implanted…
Singaporean subsidiary VALLAURIX completes preliminary evaluation of VLRX001 SUMMARY Clinuvel expands pipeline with VLRX001 targeting skin disorders First therapeutic target: vitiligo (depigmentation disorder) as maintenance therapy following SCENESSE® (afamelanotide 16mg) Innovation is the result of collaboration between Clinuvel and the international research community Proprietary technology of VALLAURIX PTE LTD, a majority-owned Clinuvel subsidiary Recent clinical research has demonstrated a renaissance in the demand for novel melanocortin molecules Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA: UR9; ADR: CLVLY) today announced that its Singaporean subsidiary VALLAURIX PTE LTD has successfully completed initial in-vitro development of VLRX001, an innovative melanocortin analogue. VLRX001 is an…

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