Announcements

Clinuvel's company releases, including archives.

Proposal to acquire all the outstanding shares in Clinuvel Pharmaceuticals Ltd

28 Jul 2014

Mr Jack Wood

Clinuvel receives an unsolicited bid for the Company

Clinuvel Pharmaceuticals Limited (“Clinuvel”; ASX: CUV) received an unsolicited proposal from Retrophin, Inc. (“Retrophin” NASDAQ: RTRX)  on July 17, 2014 to acquire all of the shares in Clinuvel for either 0.175 Retrophin shares per Clinuvel share (valued at $2.14 per share based on the one month VWAP of Retrophin shares on 16 July 2014) or $2.17 in cash per share via a scheme of arrangement. The Retrophin bid values Clinuvel at approximately A$95 million2. The proposal is subject to numerous conditions. Retrophin has acquired a stake of approximately 4.88% in Clinuvel. The Board of Directors of Clinuvel is evaluating all…

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…
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Investors' Blog Posts

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