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CLINUVEL's company releases, including archives.

Tuesday, 16 August 2016 01:05

Clinuvel Newsletter - August 2016

Wednesday, 10 August 2016 02:42

Form 603 - August 10, 2016 (ACN 108 768 896)

Thursday, 04 August 2016 08:56

Appendix 3Y

Wednesday, 03 August 2016 09:07

Appendix 3B

Clinuvel prepares New Drug Application (NDA) for the treatment of erythropoietic protoporphyria (EPP) Executive summary: FDA requirement for combination therapy model replicating clinical studies protocol in vitiligo fulfilled Safety of the combination therapy confirms observations in clinical trials CUV102 and CUV103 Clinuvel will request a guidance meeting with the FDA to discuss the upcoming vitiligo trial in North America Safety data add to the New Drug Application package to be submitted to the FDA for erythropoietic protoporphyria (EPP) Global experts agree on the lack of current satisfactory treatment in vitiligo Clinuvel Pharmaceuticals [ASX: CUV; Nasdaq International Designation ADR: CLVLY; Xetra-DAX:…
Friday, 29 July 2016 05:15

Appendix 4C - Q4 FY16

Clinuvel prepares New Drug Application (NDA) for the treatment of erythropoietic protoporphyria (EPP) Executive summary: FDA concludes initial review of datasets on SCENESSE® in EPP FDA deems datasets satisfactory for submission of New Drug Application Pre-NDA meeting with FDA to be scheduled to discuss timelines and procedure Clinuvel will request rolling review of NDA under Fast Track designation Clinuvel to request Priority Review to shorten review from 10 to 6 months Clinuvel Pharmaceuticals [ASX: CUV; Nasdaq International Designation ADR: CLVLY; Xetra-DAX: UR9] today announced that the US Food and Drug Administration (FDA) has concluded an initial review of Clinuvel’s clinical…
Executive summary: FDA awards Fast Track Designation¹ to expedite review of SCENESSE® in EPP NDA filing allowed on a rolling basis FDA hosting a Scientific Workshop² on EPP to learn more about disease and drug treatment Clinuvel Pharmaceuticals [ASX: CUV; Nasdaq International Designation ADR: CLVLY; Xetra-DAX: UR9] today announced that the US Food and Drug Administration (FDA) has granted SCENESSE® (afamelanotide 16 mg) Fast Track designation for the treatment of erythropoietic protoporphyria (EPP). This designation recognises the severity of EPP and the unmet medical need of the disorder in the US. SCENESSE® is commercially available for EPP patients in Europe.3US…
Wednesday, 22 June 2016 19:00

Clinuvel’s SCENESSE® launched in Europe

First commercial delivery, SCENESSE® approved as standard of care in the Netherlands Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that its drug SCENESSE® (afamelanotide 16mg) has been launched in Europe, with the first commercial delivery of the product under European marketing authorisation.1 Patients with the rare genetic disorder erythropoietic protoporphyria (EPP) in the Netherlands will be treated with SCENESSE® starting from this week. First treatments in Austria and Germany are expected in July. SCENESSE® - standard of care in EPP The Netherlands is home to one of the largest known adult EPP patient populations in Europe.…
Response to increasing US investor interest Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced the inclusion of its Sponsored Level 1 American Depository Receipt (ADR) program in Nasdaq’s International Designation, a new visibility offering available to non-US companies. Clinuvel is the first life science company to be selected for this initiative, first launched by Nasdaq on 9 December 2015. Clinuvel’s US Investor Base and Level 1 ADR (CLVLY) Program Clinuvel’s Level I ADRs (CLVLY) have traded on the over-the-counter market since 2004. The Bank of New York Mellon is the depository bank and one ADR represents one…

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