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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…
Monday, 10 October 2016 07:31

CLINUVEL Confirms Date of Annual General Meeting

Tuesday, 20 September 2016 01:25

Chair's Letter

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

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