Shares in Clinuvel Pharmaceuticals Limited (ASX: CUV) opened more than 40% higher this morning after receiving FDA approval for its marquee product SCENESSE.

About Clinuvel

Clinuvel is a global biopharmaceuticals company with a focus on developing and delivering treatments for patients with a range of severe genetic and skin disorders. Clinuvel’s main product is called SCENESSE, which it develops and self-distributes.

Today’s Announcement

The US Food and Drug Administration (FDA) has approved the company’s SCENESSE product, which is a drug that treats a rare genetic metabolic disorder that causes absolute intolerance to light. The drug has been approved to “increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).”

Whilst some of the words above might make your head hurt, this is clearly a huge win for Clinuvel who has been developing the drug for a number of years. The FDA approval will be a great cause for celebration for people suffering from the rare disorder, whom may now be able to access the sort of freedom they could only dream of in the past.

Shares in Clinuvel opened 42% higher this morning and climbed a further 6% to a high of $42.38, before drifting lower to be trading up 38% at the time of writing.

Reaction To The Announcement

CEO Dr Phillipe Wolgen was pragmatic in his response to the news, saying; “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.”

Clinuvel’s Chief Scientific Officer Dr Dennis Wright did not hide his joy, saying; “I cannot start to describe what it means to dedicate a large portion of one’s professional life to a single molecule and for one group of patients, while not knowing the regulatory outcome.”

Mr Wright went on to add, “The outcome today is greatest for the patients and their families who kept asking us to continue the R&D of SCENESSE despite the obstacles we faced. The approval of SCENESSE today is deserved based on its safety an medical benefits to patients.”

The company will host an investor and analyst teleconference at 4.30pm today to discuss the announcement and what this means going forward for the company.

Is It Too Late To Buy Now?

If you aren’t lucky enough to already own shares in Clinuvel, I wouldn’t be rushing in now. Instead, I’d let the dust settle and see what management have to say about the FDA approval before weighing up the future investment case.

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Disclaimer: Any information contained in this article is limited to general financial/investment advice only. The information has not taken into account your specific needs, goals or objectives, so please consider consulting a licenced and trusted adviser before acting on the information. Please read The Rask Group’s Financial Services Guide (FSG) for more information. This article is authorised by Owen Raszkiewicz of The Rask Group, which is a corporate authorised representative No. 1264179 of Strawman Pty Ltd (ACN: 610 908 211) (AFSL: 501 223).

At the time of publishing, Luke has no financial interest in any companies mentioned.