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CLINUVEL's company releases, including archives.

Appendix 4CMelbourne, Australia and Leatherhead, UK, 30 July 2018CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY), a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic and skin disorders, today announced its Appendix 4C – Quarterly Cashflow report for the period 01 April to 30 June 2018. All figures are rounded and reported in Australian dollars. Cash receipts from customers for the quarter were $10,388,000, a 66% increase compared to the same quarter last year ($6,247,000 for the April to June 2017 quarter). Orders received from European Erythropoietic Protoporphyria…
Historic New Drug Application for the use of SCENESSE® in rare metabolic disorder EPP EXECUTIVE SUMMARY First NDA for SCENESSE® (afamelanotide 16mg) in the United States First-line therapy proposed as systemic photoprotection for EPP patients Submission of data from five clinical trials in EPP, pooled data, Compassionate Use, Special Access Schemes, and real-world experience from European use Nearly 6,700 afamelanotide doses administered to more than 800 patients Priority Review requested to FDA CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) today announced that it has completed the submission of a New Drug Application (NDA) for its drug…
Friday, 22 June 2018 10:05

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NICE MAINTAINS ITS POSITION NOT TO RECOMMEND SCENESSE® FOR REIMBURSEMENTCLINUVEL TO APPEAL NICE DECISION IN ENGLANDMelbourne, Australia, and Leatherhead, UK, 23 May 2018 CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) today announced that the English National Institute of Health and Care Excellence (NICE) maintained its position not to recommend CLINUVEL’s drug SCENESSE® (afamelanotide 16mg) for reimbursement in England (see ASX announcement 21 December 2017). In its evaluation of novel medicinal therapies NICE advises the English National Health Service (NHS) whether a proposed therapy meets its economic criteria for reimbursement or not. CLINUVEL will now proceed to…
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