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CLINUVEL's company releases, including archives.

Monday, 31 October 2016 14:16

Appendix 4C

Thursday, 27 October 2016 05:36

Appendix 4G

Monday, 24 October 2016 03:46

CLINUVEL relocates Melbourne office

Melbourne, Australia, October 24, 2016 CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY) today announced that its head office in Melbourne has relocated. The new address, which will also be the Company’s Registered Address, is: Level 6 15 Queen Street Melbourne Victoria, Australia, 3000 All telephone and fax numbers remain the same. - End - For more information contact: CLINUVEL PHARMACEUTICALS LTD T: +61 3 9660 4900 E: This email address is being protected from spambots. You need JavaScript enabled to view it. This release to the Australian Securities Exchange and to press may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and…
Melbourne, Australia and Leatherhead, UK, 24 October 2016 The US Food and Drug Administration (FDA) will today host a scientific workshop on erythropoietic protoporphyria (EPP) at the FDA campus in Silver Spring. The workshop is open to all EPP stakeholders, with the FDA seeking perspective on EPP disease symptoms, its impact on daily life, experience with current treatment regimens for EPP, and aspects of clinical development of products intended to treat EPP. The meeting will also be available for viewing via webcast for those who have registered, and public online archive thereafter. CLINUVEL’s product SCENESSE® (afamelanotide 16mg) has been evaluated…
Wednesday, 26 October 2016 21:31

Annual Report for the year ended 30 June 2016

CLINUVEL's Annual Report for the year ended 30 June 2016.
Tuesday, 18 October 2016 02:08

SCENESSE® NICE ENGLAND UPDATE

Melbourne, Australia and Leatherhead, UK, 18 October 2016 CLINUVEL [ASX: CUV; Nasdaq International Designation ADR: CLVLY; Xetra-DAX: UR9] today announced an update on the review by National Institute for Health and Care Excellence (NICE) regarding its drug SCENESSE® (afamelanotide 16mg) for adult patients with erythropoietic protoporphyria (EPP) in England.1 On 24 March 2016 CLINUVEL announced it had participated in a public workshop with NICE where it had proposed SCENESSE® to be evaluated under the Highly Specialised Technology (HST) Programme for its introduction in England. HST evaluations are recommendations on the use of new and existing highly specialised medicines and treatments…
CLINUVEL PHARMACEUTICALS LTD [ASX: CUV; Nasdaq International Designation ADR: CLVLY; Xetra-DAX: UR9] today announced that it will meet with the US Food and Drug Administration (FDA) on 7 November to formally discuss lodging its new drug application (NDA) for the novel drug SCENESSE® (afamelanotide 16mg). The pre-NDA meeting will focus on finalising requirements for filing SCENESSE® with the FDA for the treatment of adult patients with the rare genetic disorder erythropoietic protoporphyria (EPP). “This is the last step required of CLINUVEL before we ask the FDA to review the risk-benefit profile of SCENESSE® in a submitted dossier,” CLINUVEL’s Acting Chief…
Thursday, 13 October 2016 09:34

FDA SCHEDULES PRE-NDA MEETING FOR SCENESSE®

On 7 November the US Food and Drug Administration (FDA) will hold a meeting with CLINUVEL to discuss the submission a New Drug Application (NDA) for SCENESSE® (afamelanotide 16mg) in the treatment of erythropoietic protoporphyria (EPP). Executive summary: The FDA scheduled a pre-NDA1 meeting on 7 November to discuss CLINUVEL’s planned US regulatory submission for SCENESSE® A key focus will be the establishment of Risk Evaluation and Mitigation Strategies (REMS) and post-authorisation safety measures Under Fast Track Designation² – one of FDA’s Expedited Programs for Serious Conditions – submission of the NDA is allowed on a rolling basis Application fees…

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