Analyst Coverage

Wednesday, 04 April 2018

CLSA: “Pharma M&A increasing – who’s next in Oz?”

Positive catalysts for ongoing M&A activity in the pharma sector We believe there are a number of positive catalysts for ongoing pharma/biotech M&A activity in the near term. These include: 1) increasing cost of pharma R&D associated with fewer new drug successes per dollar of R&D spent; and 2) recent US tax reform, leading...
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Sunday, 30 June 2013

Nomura update “Breakthrough status: Aust biotechs could apply”

The FDA has granted ‘breakthrough status’ this year on 15 potential drugs, mostly for cancer and rare diseases The US Food and Drug Administration already has numerous ways it can speed up the market authorisation of new medicines, ranging from ‘accelerated approvals’ to ‘priority reviews’ to its fast-track program. Even so, sometimes the existing...
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Monday, 06 May 2013

Nomura update “Funds to be used for further clinical development”

CUV has successfully raised AUD6.3mn via a private placement to international institutional and professional investors. The Placement was conducted at price of AUD2.136 per share, representing a 4.3% premium to the 20-day volume weighted average price on April 29 and 15.1% to the closing price on April 30.
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Thursday, 04 April 2013

Nomura Quick Note: “Delay for European EPP decision”

CLINUVEL filed its MAA for afamelanotide 16mg implant on 6 February 2012 for the preventative treatment of the orphan light intolerance disorder erythropoietic protoporphyria (EPP).
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Wednesday, 27 February 2013

Nomura update “We believe the EMA decision is due in the short-term”

1H13 – awaiting EMA registration decision Anchor themes We continue to believe that there is a very high possibility of CUV getting afamelanotide to the market. This points to cashflow from sales, and sooner than for most other biotechnology companies the to access the full report.
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Wednesday, 19 December 2012

Nomura update “Statistically significant results – will progress to a Phase IIb”

CUV announced successful, statistically significant results from its US Phase IIa pilot study (CUV102) of its afamelanotide 16mg implant in the pigmentation disorder Vitiligo.
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Tuesday, 16 October 2012

Nomura Quick Note: “Vitiligo journal article released”

Preliminary observations from CUV’s open-label Phase IIa US pilot trial of its drug, afamelanotide, in four patients with Vitiligo (a de-pigmenting skin disease) have been published in the journal Archives of Dermatology. In total, 56 patients are participating in the trial, with results from the six-month treatment period expected to be released before the...
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Wednesday, 29 August 2012

Nomura Update “F12 – good progress, expect a F13 EMA decision”

Vitiligo market is underserved in our view – CUV’s potential product addresses this.
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Wednesday, 08 August 2012

Nomura Update “Funds to be used for further clinical development”

CUV raised AUD6.0mn via a placement at a price of AUD1.75 per share. Management state that the funds raised in the placement will be used for: 1) a US Phase III clinical trial in erythropoietic protoporphyria (EPP); 2) a global clinical trial program in patients with Vitiligo; and 3) working capital during the evaluation...
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Tuesday, 22 May 2012

Nomura Quick Note: “Launches US Phase III trial for EPP treatment”

CLINUVEL Pharmaceuticals (CUV) has started its confirmatory Phase III US study of the novel drug afamelanotide, for the treatment of erythropoietic protoporphyria (EPP), a rare light intolerance disorder. The Phase III trial protocol has been designed in close consultation with the US Food and Drug Administration (FDA).
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Thursday, 26 April 2012

Nomura Quick Note: “Afamelanotide receives approval in Switzerland”

CUV announced that their afamelanotide product has been accepted by two health insurers in Switzerland for full reimbursement for the prophylactic treatment of patients with erythropoietic protoporphyria (EPP), a rare genetic disease causing extreme intolerance of skin to light.
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Tuesday, 27 March 2012

Nomura Update “Considerable upside should NSV trials be successful”

NSV is a de-pigmenting disease that affects c10mn persons in the US and EU. CUV’s afamelanotide is being evaluated as a combination therapy with narrowband UVB light therapy in two clinical studies in patients with NSV. In early Phase II trial results presented at a recent conference, the NB-UVB plus afamelanotide group showed earlier...
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Friday, 16 March 2012

Nomura Quick Note: “Vitiligo and EPP opportunities progress”

CUV has released: 1) clinically impressive interim Phase II Vitiligo trial results; and 2) US FDA agreement to be allowed to conduct a Phase III study in erythropoietic protoporphyria (EPP).
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