CUV.AX - Clinuvel Pharmaceuticals Limited

ASX - ASX Delayed Price. Currency in AUD
31.85
-0.50 (-1.55%)
At close: 4:10PM AEDT
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Previous Close32.35
Open31.60
Bid31.85 x 0
Ask29.41 x 0
Day's Range31.06 - 32.48
52 Week Range14.10 - 45.88
Volume234,503
Avg. Volume330,523
Market Cap1.559B
Beta (3Y Monthly)0.47
PE Ratio (TTM)87.02
EPS (TTM)0.37
Earnings DateAug 30, 2018
Forward Dividend & Yield0.03 (0.07%)
Ex-Dividend Date2019-09-04
1y Target Est32.70
  • Reuters

    Clinuvel says U.S. pricing of rare disorder drug will not top European levels

    Australian drugmaker Clinuvel Pharmaceuticals Ltd said on Wednesday the pricing of its recently approved treatment for a rare genetic disorder in the United States will not top its price in Europe. The drug, Scenesse, was approved by the U.S. Food and Drug Administration on Tuesday to treat erythropoietic protoporphyria (EPP), a painful disorder that causes the skin to itch, burn, and scar in some rare cases, when exposed to sunlight and some types of artificial light. Scenesse is available in Europe since 2014, where its price ranges between 70,000 euros ($76,811.00) and 100,000 euros ($109,730.00) per patient per year.

  • Australian Drug Maker Jumps 51% After Winning FDA Approval
    Bloomberg

    Australian Drug Maker Jumps 51% After Winning FDA Approval

    (Bloomberg) -- Clinuvel Pharmaceuticals Ltd. surged the most in five years after the U.S. Food and Drug Administration approved its treatment for a rare skin disorder that causes sensitivity to light.Shares of the Melbourne-based bio-pharmaceutical firm jumped as much as 57% in Sydney, the most since October 2014, after the U.S. allowed the use of the drug Scenesse to treat erythropoietic protoporphyria. Clinuvel rose to a record high of A$44.39, valuing the company at A$2.2 billion ($1.5 billion).Erythropoietic protoporphyria induces skin damage from exposure to light, forcing patients to “lead an indoor or nocturnal existence,” Clinuvel said in a release. Scenesse treats the genetic disorder by increasing the skin’s levels of melanin and blocking ultraviolet radiation and sunlight, according to the company’s website.Scenesse is the first FDA-approved treatment to help erythropoietic protoporphyria patients increase their exposure to light, the agency said. The drug was approved for use in Europe in December 2014.Clinuvel intends to distribute Scenesse directly to U.S. hospitals within 12 months, Chief Executive Officer Dr. Philippe Wolgen said in a phone interview. The company also plans to sell the drug at the same price worldwide.A single price-point “is quite alien to our industry,” Wolgen said. “We wanted to show the American payers that they would not be paying more for a pharmaceutical product than the Europeans and the Swiss do.”(Update with share price, comments from company)To contact the reporter on this story: Jackie Edwards in Sydney at jedwards160@bloomberg.netTo contact the editors responsible for this story: Lianting Tu at ltu4@bloomberg.net, Tim SmithFor more articles like this, please visit us at bloomberg.com©2019 Bloomberg L.P.

  • GlobeNewswire

    FDA Approves SCENESSE® For Genetic Disorder

    The US Food and Drug Administration (FDA) has approved a new drug as the first ever treatment for a rare genetic metabolic disorder which causes absolute intolerance to light. SCENESSE® (afamelanotide 16mg), the first drug developed by Australian biopharmaceutical company CLINUVEL, has been approved to “increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)”.

  • Reuters

    UPDATE 2-FDA approves Clinuvel's rare genetic disorder treatment, shares at record high

    The U.S. Food and Drug Administration approved Australian drugmaker Clinuvel Pharmaceuticals Ltd's treatment for a rare inherited disorder that causes skin damage from exposure to light, sending its shares to a record high on Wednesday. The treatment, Scenesse, is an under-the-skin implant that treats erythropoietic protoporphyria (EPP), a painful disorder that causes the skin to itch, burn, and scar in some rare cases, when exposed to sunlight and some types of artificial light. "With the approved New Drug Application, Scenesse is the first global systemic photoprotective drug for the treatment of patients with EPP," Clinuvel said in a statement to the Australian stock exchange.

  • Can You Imagine How Elated Clinuvel Pharmaceuticals's (ASX:CUV) Shareholders Feel About Its 834% Share Price Gain?
    Simply Wall St.

    Can You Imagine How Elated Clinuvel Pharmaceuticals's (ASX:CUV) Shareholders Feel About Its 834% Share Price Gain?

    It hasn't been the best quarter for Clinuvel Pharmaceuticals Limited (ASX:CUV) shareholders, since the share price has...

  • What Do Analysts Think About Clinuvel Pharmaceuticals Limited's (ASX:CUV) Future?
    Simply Wall St.

    What Do Analysts Think About Clinuvel Pharmaceuticals Limited's (ASX:CUV) Future?

    Clinuvel Pharmaceuticals Limited's (ASX:CUV) most recent earnings announcement in August 2019 confirmed that the...

  • Here's Why I Think Clinuvel Pharmaceuticals (ASX:CUV) Might Deserve Your Attention Today
    Simply Wall St.

    Here's Why I Think Clinuvel Pharmaceuticals (ASX:CUV) Might Deserve Your Attention Today

    Like a puppy chasing its tail, some new investors often chase 'the next big thing', even if that means buying 'story...

  • Is Clinuvel Pharmaceuticals Limited's (ASX:CUV) ROE Of 37% Impressive?
    Simply Wall St.

    Is Clinuvel Pharmaceuticals Limited's (ASX:CUV) ROE Of 37% Impressive?

    One of the best investments we can make is in our own knowledge and skill set. With that in mind, this article will...

  • Why Clinuvel Pharmaceuticals Limited (ASX:CUV) Could Have A Place In Your Portfolio
    Simply Wall St.

    Why Clinuvel Pharmaceuticals Limited (ASX:CUV) Could Have A Place In Your Portfolio

    Clinuvel Pharmaceuticals Limited (ASX:CUV) is a stock with outstanding fundamental characteristics. When we build an...

  • GlobeNewswire

    US FDA Review for SCENESSE® Extended by Three Months

    MELBOURNE, Australia, June 03, 2019 -- CLINUVEL PHARMACEUTICALS LTD today published that the US Food and Drug Administration (FDA) Division of Dermatology and Dental Products.

  • Does Clinuvel Pharmaceuticals Limited's (ASX:CUV) CEO Pay Reflect Performance?
    Simply Wall St.

    Does Clinuvel Pharmaceuticals Limited's (ASX:CUV) CEO Pay Reflect Performance?

    Philippe Wolgen has been the CEO of Clinuvel Pharmaceuticals Limited (ASX:CUV) since 2005. First, this article will...

  • Despite Its High P/E Ratio, Is Clinuvel Pharmaceuticals Limited (ASX:CUV) Still Undervalued?
    Simply Wall St.

    Despite Its High P/E Ratio, Is Clinuvel Pharmaceuticals Limited (ASX:CUV) Still Undervalued?

    This article is written for those who want to get better at using price to earnings ratios (P/E ratios). We'll look at Clinuvel Pharmaceuticals Limited's (ASX:CUV) P/E ratio and reflect on what it tells us about the company's share...

  • How Much Of Clinuvel Pharmaceuticals Limited (ASX:CUV) Do Insiders Own?
    Simply Wall St.

    How Much Of Clinuvel Pharmaceuticals Limited (ASX:CUV) Do Insiders Own?

    Want to participate in a research study? Help shape the future of investing tools and earn a $60 gift card! If you want to know who really controls Clinuvel Pharmaceuticals Limited (ASX:CUV), then you'll have to look at the makeup of...

  • Who Has Been Buying Clinuvel Pharmaceuticals Limited (ASX:CUV) Shares?
    Simply Wall St.

    Who Has Been Buying Clinuvel Pharmaceuticals Limited (ASX:CUV) Shares?

    Want to participate in a short research study? Help shape the future of investing tools and you could win a $250 gift card! It is not uncommon to see companiesRead More...

  • Should You Be Excited About Clinuvel Pharmaceuticals Limited’s (ASX:CUV) 34% Return On Equity?
    Simply Wall St.

    Should You Be Excited About Clinuvel Pharmaceuticals Limited’s (ASX:CUV) 34% Return On Equity?

    While some investors are already well versed in financial metrics (hat tip), this article is for those who would like to learn about Return On Equity (ROE) and why it Read More...

  • GlobeNewswire

    US FDA sets PDUFA date for SCENESSE®

    Executive summary New Drug Application submitted in accordance with section 505(b) of the Federal Food, Drug, and Cosmetic Act, filed in accordance with 21 CFR.

  • GlobeNewswire

    Phase II study: SCENESSE® in combination with narrowband ultraviolet B (NB-UVB) achieves repigmentation in vitiligo

    MELBOURNE, Australia and SINGAPORE, Dec. 19, 2018 -- SUMMARY Phase II study in vitiligo, a treatment-resistant disease1n=21, patients of Asian ethnicity, darker skin.

  • Is Clinuvel Pharmaceuticals Limited’s (ASX:CUV) Balance Sheet A Threat To Its Future?
    Simply Wall St.

    Is Clinuvel Pharmaceuticals Limited’s (ASX:CUV) Balance Sheet A Threat To Its Future?

    The direct benefit for Clinuvel Pharmaceuticals Limited (ASX:CUV), which sports a zero-debt capital structure, to include debt in its capital structure is the reduced cost of capital. However, the trade-off Read More...