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CLINUVEL's company releases, including archives.

NICE’s technical team invited stakeholders with an interest in the treatment of erythropoietic protoporphyria (EPP) Executive summary SCENESSE® evaluated as part of the Highly Specialised Technologies Programme (HST) in UK HST Programme review of relatively high cost - low volume technology Evaluation of the drug as an innovative therapy for unmet clinical need in a rare disorder SCENESSE® to be available in trained and accredited expert EPP centres in the UK EPP patients acknowledged to be impaired due to light deprivation and isolation Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that the National Institute for Health…
Friday, 18 March 2016 16:12

s.708A Notice

Friday, 18 March 2016 16:11

Appendix 3B

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…

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