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Appendix 4C Melbourne, Australia and Leatherhead, UK, 30 July 2018 CLINUVEL 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 […]
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Change in substantial holding Download attachments: 20180717Form604_FIL.pdf
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Change in substantial holding Download attachments: 20180704Form604_Lagoda.pdf
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 […]
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 […]
Change in substantial holding Download attachments: 20180517Changeinsubstantialholding.pdf
Change in substantial holding Download attachments: 20180516Changeinsubstantialholding.pdf
CLINUVEL REGULATORY UPDATE EUROPEAN SAFETY DATA ADDS TO US FDA FILING (NDA) ? European Annual and Periodic Reports show positive benefit-risk and safety profile maintained? SCENESSE® implants administered globally to date: >5,100 (>4,000 to EPP patients)? >99% treatment compliance rate in European EPP population maintained? >85% of European patients on treatment consented to inclusion in […]
Change in substantial holding Download attachments: 20180501NoticeofChangeofInterestsofSubstantialHolder.pdf
