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CLINUVEL's company releases, including archives.

Friday, 18 March 2016 16:10

Form 604 - March 18, 2016

Tuesday, 15 March 2016 17:34

Form 604 - March 15, 2016

As part of the European distribution of SCENESSE® (afamelanotide 16mg) in specialist centres Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that its European commercial team is conducting site training and accreditation at the first of the European expert porphyria centres this week. Following training these centres of expertise will be accredited to prescribe Clinuvel’s drug SCENESSE® (afamelanotide 16mg) to adult patients diagnosed with erythropoietic protoporphyria (EPP).1 TREATMENT OF ERYTHROPOIETIC PROTOPORPHYRIA (EPP) SCENESSE® has been approved by the European Medicines Agency (EMA) for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with EPP. The…
** Not for release or distribution in the United States ** Funding supports European commercial distribution of SCENESSE® (afamelanotide 16mg) Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) has successfully raised A$8.3 million dollars via a private placement (“Placement”) to existing and new international institutional and professional investors. The Placement was made at a price of A$3.30 per share, representing an issue price equal to the closing price on 10th March and a 2.9% discount to the 10th March 10 day volume weighted average price. The funds raised will enable Clinuvel to pursue the European commercialisation program for its…
Friday, 11 March 2016 19:03

Request for Trading Halt

Friday, 19 February 2016 16:14

Appendix 4D and Half Year Report

Tuesday, 16 February 2016 10:08

Clinuvel brief on European commercialisation

Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced an update on the commercialisation of its novel drug SCENESSE® (afamelanotide 16mg) in adult patients with erythropoietic protoporphyria (EPP) in Europe.1 Clinuvel has been working towards finalising distribution infrastructure, with a focus on a Risk Management Plan (RMP) and pharmacovigilance in accordance to EU legislation to undertake the long term follow up of EPP patients receiving SCENESSE®.2 Patients will be treated in accordance with a Post-Authorisation Safety (PASS) Protocol. EUROPEAN PRICING AND REIMBURSEMENT Payors across Europe acknowledge the need to treat EPP, a rare genetic disorder which is regarded…
Afamelanotide recognised as potential treatment for rare metabolic disorders Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that its lead drug SCENESSE® (afamelanotide 16mg) has received an additional orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of cutaneous variants of porphyria. The ODD recognises the potential of afamelanotide to treat or prevent symptoms in rare forms of porphyria and offers incentives to Clinuvel to develop the drug for these patients. SCENESSE® (AFAMELANOTIDE 16MG) AND CUTANEOUS PORPHYRIAS SCENESSE® has been clinically evaluated as a photoprotective drug in one severe form of…
Monday, 08 February 2016 09:18

Presentation to international porphyria patient group

Thursday, 28 January 2016 18:31

Appendix 4C - Q2 FY16

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