About CLINUVEL

Announcements

CLINUVEL's company releases, including archives.

APPEAL UPHELD AGAINST NICE RECOMMENDATION IN ENGLAND Appeal Panel remits to NICE evaluation committee to readdress the assessment underlying the reimbursement of SCENESSE® for the treatment of English EPP patients Melbourne, Australia and Leatherhead, UK, 10 October 2018 CLINUVEL PHARMACEUTICALS LTD today announced that the Appeal Panel of the National Institute of Health and Care Excellence (NICE) – the body responsible for providing evidence-based guidance on health and social care to the National Health Service (NHS) in England – has published a decision following an oral Appeal Hearing as part of the ongoing Highly Specialised Technology (HST) evaluation of CLINUVEL’s…
Friday, 05 October 2018 17:19

Chair Letter to Shareholders

Wednesday, 03 October 2018 15:33

CLINUVEL Confirms AGM Date

CLINUVEL CONFIRMS AGM DATE Melbourne, Australia, 3 October 2018 CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) today announced it will hold its 2018 Annual General Meeting of shareholders on Wednesday 21 November 2018 at 10.00am AEDT at The Events Centre at Collins Square, Tower 2, Level 6, 727 Collins Street, Melbourne, VIC 3008 Australia. A formal Notice of Meeting and the Company’s Annual Report will be lodged with the ASX no later than Friday 19 October 2018. – End – About CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY; XETRA-DAX: UR9)…
CLINUVEL INITIATES VARIEGATE PORPHYRIA PROOF OF CONCEPT STUDY SCENESSE® to be clinically evaluated in second cutaneous porphyria Melbourne, Australia, 01 October 2018 EXECUTIVE SUMMARY Proof of concept Phase IIa study in genetic metabolic disorder variegate porphyria (VP) Six patients evaluated following up to six doses of SCENESSE® in 2019 CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) today announced that it has reached agreement with two European porphyria expert centres on a clinical trial protocol to conduct a Phase IIa proof of concept study evaluating the safety and effectiveness of SCENESSE® (afamelanotide 16mg) in variegate porphyria (VP).…
Tuesday, 11 September 2018 17:06

Appendix 3B

Wednesday, 05 September 2018 17:23

US FDA Update

US FDA UPDATE Agency requests additional information on SCENESSE® new drug application for the treatment of EPP Melbourne, Australia, and New York, USA, 05 September 2018 EXECUTIVE SUMMARY FDA requests further documentation as part of the new drug application (NDA) Decision on Priority Review will be made following satisfaction of all agency requests CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) today announced that the US Food and Drug Administration (FDA) has issued a request for further documentation to support CLINUVEL’s new drug application (NDA) for SCENESSE® (afamelanotide 16mg). This additional information covers product manufacturing information and…
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