The Clinuvel Pharmaceuticals Limited (ASX: CUV) share price is now up around 150% over just the past year after rising from $8.89 this time last year to $22.13 today.
Clinuvel is a global biopharmaceutical company that develops treatment for severe and genetic skin disorders that has produced a drug named SCENESSE.
It reports the drug is on the verge of approval by the US drugs regulator the FDA. According to the company the FDA is set to communicate labelling and post marketing requirements for the drug in April 2019, with July 8 2019 a potential final review date that could see the drug approved assuming the FDA's final hurdles for the drug are all cleared.
The SCENESSE drug has already been commercialised in Europe (approved in 2014) with total sales from customers hitting $10.75 million for the quarter ending September 30 2018 to produce an operating cash profit of $7.8 million. The pharmaceutical also had $44.4 million cash on hand at September quarter end to suggest its well funded for further research ahead.
Clinuvel now has a market value of more than $1 billion and the stock has been rising as it moves closer to FDA approval that could send its sales and profits soaring.
However, investors should remember FDA approval is never guaranteed, as pharmaceutical manufacturer Starpharma Ltd (ASX: SPL) recently showed, after its application for a clinical gel product approval was knocked back by the FDA.
