Announcements

Clinuvel's company releases, including archives.

Clinuvel Newsletter - July 2014

16 Jul 2014

SCENESSE® (afamelanotide) receives US orphan-drug designation in Hailey-Hailey Disease

Clinuvel’s drug acknowledged as potential treatment of rare HHD Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that afamelanotide, the active ingredient in its proprietary drug SCENESSE®, has received orphan-drug designation from the US Food and Drug Administration (FDA) for the rare Hailey-Hailey Disease (HHD, also known as familial benign chronic pemphigus). Orphan-drug designation is granted by the FDA’s Office of Orphan Products Development to drugs which have the potential to diagnose or treat rare conditions, defined as those affecting less than 200,000 individuals in the United States. The orphan designation entitles Clinuvel to technical assistance throughout…

Appendix 3B

20 May 2014

Notice s708A

20 May 2014

Form 603: Notice of Initial Substantial Holder

20 May 2014

SCENESSE® receives European orphan designation in Hailey-Hailey Disease

Afamelanotide 16mg recognised for potential to treat rare Hailey-Hailey Disease Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that its drug SCENESSE® (afamelanotide 16mg) has received an orphan designation from the European Medicines Agency (EMA) for the rare Hailey-Hailey Disease (HHD, also known as familial benign chronic pemphigus) . HHD is a rare, lifelong, inherited disorder causing a defect in the adherence of epidermal skin cells (keratinocytes). Clinically this causes periodic eruption of plaque-like lesions, blisters and ulcerations on areas where skin folds (flexural), often on the neck, armpits or groin. Most patients have permanent lesions. Current…

Management update

Clinuvel’s management address patients’, shareholders’ questions Over an extended period of time Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) has received a number of questions from patients, shareholders and the broader biotechnology community regarding the company’s program and the progress being made towards regulatory approval by the EMA (European Medicines Agency) of the company’s drug SCENESSE® (afamelanotide 16mg). In this release, Clinuvel’s Chairman Stan McLiesh and CEO Dr Philippe Wolgen address those questions most frequently asked of the company. How long will it take to complete the EMA review of SCENESSE®?The EMA review is estimated to be completed…

Clinuvel Placement completed successfully

** Not for release or distribution in the United States ** Placement of new ordinary shares to fund clinical and product development goals Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) has successfully raised A$7.2 million via a private placement (“Placement”) to Asian and European institutional and professional investors. Included in the Placement are subscriptions by the Board of Directors of Clinuvel for a total of $0.3 million at terms equivalent to all participants to the Placement. The subscriptions by the Board of Directors are subject to shareholder approval*. The Placement was conducted at price of A$1.658 per share,…

Trading Halt

12 May 2014

Request for Trading Halt

12 May 2014
Page 1 of 33

Investors' Blog Posts

In 2010, Clinuvel announced that it would commence a clinical trial of a new drug for vitiligo. In late 2012 the first treatment results...

Read More

Clinuvel Non-Executive Director Brenda Shanahan has been honoured at The Australian Financial Review and Westpac Group Woman of Influence...

Read More

Since we publicly announced our vitiligo program in 2010, the entire Clinuvel team has aimed to gain a better understand this disease, its...

Read More

Related Webcasts

Taking on Vitiligo, a depigmentation disorder of the skin. In 2010, Clinuvel ventured into an area of dermatology where no other pharmaceut...

Watch now

Taking on Vitiligo, a depigmentation disorder of the skin. In 2010, Clinuvel ventured into an area of dermatology where no other pharmaceut...

Watch now

Taking on Vitiligo, a depigmentation disorder of the skin. In 2010, Clinuvel ventured into an area of dermatology where no other pharmaceut...

Watch now

Investor Spotlight