Company Overview and News

Clinuvel: Turtle Or Race Horse? Both Have Their Qualities

2017-12-01 seekingalpha
Clinuvel Pharmaceuticals (CLVLY) held their annual general shareholder meeting (AGM) on November 28th, 2017, revealing new pockets for growth and a re-positioning of the company.

Clinuvel: Laying The First Brick For A Fortress Of Commercial Success

2017-01-19 seekingalpha
Clinuvel Pharmaceuticals, after many, many years, finally became a commercial operation with the introduction of Scenesse as the first treatment for EPP.

Clinuvel Pharmaceuticals Ltd prepares for new drug application in the U.S.

SCENESSE has been developed for the treatment of erythropoietic protoporphyria (EPP), a rare genetic enzymatic disorder causing lifelong absolute light intolerance. Clinuvel will submit the modular dossier on SCENESSE on a rolling basis during the first half of 2017. After the completion of the submission of the dossier, the FDA will observe a validation period of two months. Notably, a positive benefit-risk assessment of SCENESSE by the FDA is expected to make the drug available as the first systemic photoprotectant for adult EPP patients.

Clinuvel Pharmaceuticals Ltd fulfils pre-clinical safety of vitiligo drug

Clinuvel Pharmaceuticals Ltd (ASX:CUV) has fulfilled an important FDA requirement by demonstrating the safety of its drug SCENESSE in combination with ultraviolet light for the pigmentation disorder vitiligo. The company will now engage with the FDA regarding the upcoming vitiligo trials and progress clinical development of the combination therapy. Clinuvel had completed one Phase II clinical trial of SCENESSE in vitiligo patients in the U.

Clinuvel Pharmaceuticals Ltd given fast track drug status by FDA

Clinuvel Pharmaceuticals Ltd (ASX:CUV) is a global biopharmaceutical company committed to developing drugs for the treatment of a range of severe skin disorders.

Photoprotection Finds Its Place in the Sun

2016-04-29 genengnews
A tanning agent that hadn’t seen the light of day since the 1980s is getting a lot of attention now that it has been transformed into a medicinal product with photoprotective and repigmentary capabilities. The medicinal product, which represents a new way of treating rare, light-sensitive skin disorders, has a sizeable global market—an estimated 45 million patients suffer disorders that make them potential candidates.

Appendix 4C - quarterly


Change in substantial holding


Clinuvel Newsletter


Change in substantial holding


Appendix 3B


s.708A Notice


Clinuvel Placement


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