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CLINUVEL's company releases, including archives.

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

Monday, 25 January 2016 19:16

Form 604 - January 25, 2016

Wednesday, 20 January 2016 17:34

CEO Brief - January 20, 2016

Monday, 18 January 2016 19:15

Form 604 - January 18, 2016

Strategy driven by key learnings from Phase II studies (CUV102, CUV103) EXECUTIVE SUMMARY · Patients of darker skin complexion respond best to SCENESSE® combination therapy with NB-UVB · Physicians’ and patients’ assessment of SCENESSE® is positive · Six-month preclinical study of SCENESSE® in combination with NB-UVB to fulfil request from US FDA to demonstrate ongoing safety · Advanced vitiligo trials planned in North America Melbourne, Australia and New York, USA, December 3, 2015 Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced its comprehensive North American development program for its drug SCENESSE® (afamelanotide 16mg) in vitiligo. CLINICAL AND…
Preliminary results of Singaporean Phase II study CUV103 in patients with naturally darker skin are consistent with results from the previous US Phase II trial (CUV102) EXECUTIVE SUMMARY PRELIMINARY RESULTS CUV103 · Positive pigmentary response to SCENESSE® in combination with narrowband ultraviolet B (NB-UVB) in patients of darker skin complexion · Combination therapy appears safe and effective · Physicians’ and patients’ assessment of SCENESSE® is positive Melbourne, Australia and Leatherhead, UK, December 3, 2015 Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced positive preliminary results from a Singaporean Phase II trial (CUV103) evaluating its drug SCENESSE® (afamelanotide…
Tuesday, 24 November 2015 13:09

Results of Meeting

Tuesday, 24 November 2015 13:08

CEO's AGM Presentation

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