The Clinuvel Pharmaceuticals Limited (ASX: CUV) share price is on a tear today, following an announcement to the ASX this morning before market open. The Clinuvel share price was sitting at $28.02 on yesterday's close, but opened this morning at $40. Clinuvel shares are now trading (at the time of writing) for $38.78 – a rise of 38.07%.
What did Clinuvel report?
Clinuvel announced that its SCENESSE treatment for erythropoietic protoporphyria (EPP), a rare genetic metabolic disorder that causes intolerance to light, has been approved by the US Food and Drug Administration (FDA). The company estimates there are between 5,000 and 10,000 patients worldwide suffering from EPP.
In the ASX release this morning, Clinuvel's Chief Science Officer Dr Dennis Wright stated:
Today is a memorable day and victory for EPP patients, their families, and the global medical community who have all supported the development and US approval of the first ever treatment for this debilitating condition… our team is granted very little time to celebrate and now needs to shift its focus to facilitating drug product access for US EPP patients.
SCENESSE has been available in Europe since 2014 and has been a strong source of revenue for Clinuvel. Until today, there was no EPP treatments available in the US (with many EPP sufferers forced to travel to Europe for treatment), so it's likely that the company will experience another surge in revenues following SCENESSE's American approval.
Although the condition affects a very small proportion of the population, SCENESSE is the only medicine available for EPP treatment, which ensures Clinuvel a virtual monopoly for the foreseeable future. This fact is no doubt adding to investor's enthusiasm this morning.
Although Clinuvel shareholders will be pleased with today's share price bump, CUV shares are still 9% off their 52-week (and all-time) high of $42.38 that the company reached in June of this year.
