Announcements

Clinuvel's company releases, including archives.

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 15:00

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…
Wednesday, 18 May 2016 16:37

SCENESSE® treatment in Europe

German Porphyria Expert Centres to start distribution of SCENESSE® (afamelanotide 16mg) Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced an update on the company’s post-authorisation distribution of SCENESSE® (afamelanotide 16mg) across Europe for adult patients with the rare disorder erythropoietic protoporphyria (EPP).1 SCENESSE® in EPP SCENESSE® is the first approved treatment for EPP, a genetic disorder characterised by acute phototoxic reactions (anaphylactoid reactions and burns) and forced withdrawal from exposure to all forms of visible light. Clinuvel conducted clinical trials of SCENESSE® in EPP from 2006 to 2013. During this time the company evaluated the treatment in…
Friday, 29 April 2016 17:38

Appendix 4C - Q3 FY16

Monday, 11 April 2016 17:53

Form 604 - April 11, 2016

Tuesday, 05 April 2016 13:05

Clinuvel Newsletter - April 2016

NICE’s technical team invited stakeholders with an interest in the treatment of erythropoietic protoporphyria (EPP) Executive summary SCENESSE® evaluated as part of the Highly Specialised Technologies Programme (HST) in UK HST Programme review of relatively high cost - low volume technology Evaluation of the drug as an innovative therapy for unmet clinical need in a rare disorder SCENESSE® to be available in trained and accredited expert EPP centres in the UK EPP patients acknowledged to be impaired due to light deprivation and isolation Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that the National Institute for Health…
Friday, 18 March 2016 16:12

s.708A Notice

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