Announcements

Clinuvel's company releases, including archives.

Thursday, 25 August 2016 18:26

Appendix 4E - Preliminary Final Report 2015/16

Tuesday, 23 August 2016 19:35

Lapse and Forfeit of Unlisted Conditional Performance Rights - Aug 23 2016

Tuesday, 16 August 2016 18:05

Clinuvel Newsletter - August 2016

Wednesday, 10 August 2016 19:48

Form 603 - August 10, 2016 (Dr Philippe Wolgen)

Wednesday, 10 August 2016 19:42

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

Friday, 05 August 2016 18:56

Appendix 3Y

Thursday, 04 August 2016 19:07

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 15:15

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…
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