Ending years of uncertainty, shares in skin treatment specialist Clinuvel (ASX:CUV) surged to all-time highs this morning after it received approval to enter the lucrative US market.

In mid-morning trading, Clinuvel shares were ahead a stunning 32 per cent to $37, after touching an all-time high of $42.38.

The previous peak was $38.95, which was touched mid-year.

Clinuvel shares have enjoyed rising popularity among US investors, particularly over the past year or so, due to its bullish prospects once it gained access to that market — the largest prospective market globally for its skin pigment treatment.


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Clinuvel’s treatment is for a genetic intolerance of light experienced by a small portion of the population.

Injection with its treatment enables suffers to go outdoors without feeling any pain or discomfort.

Clinuvel is already approved to sell its treatment in the European market, and there have been cases of Americans travelling overseas to access it.

Clinuvel has been working with the US Food and Drug Administration (FDA) for more than a decade to gain access, and with final approval in hand it has been given several years of exclusivity in marketing its product.

One of the few brokers which follows Clinuvel is Moelis, which has stated previously that access to the US market will be a key catalyst for the company’s share price, although it will take until 2022 before sales there are likely to get underway.

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