The Motley Fool

Why the CLINUVEL Pharmaceuticals share price surged 13% higher today

In morning trade the CLINUVEL Pharmaceuticals Limited (ASX: CUV) share price has pushed notably higher once again.

At the time of writing the pharmaceutical company’s shares are up 13% to $21.70.

This gain means that CLINUVEL’s shares are now up a remarkable 144% since this time last year.

Why is the CLINUVEL share price storming higher today?

Investors have been fighting to get hold of its shares this morning after the release of a positive announcement related to its SCENESSE product in the United States.

SCENESSE is a drug used for the prevention of phototoxicity and anaphylactoid reactions in adult patients with erythropoietic protoporphyria (EPP).

According to the release, the US Food and Drug Administration (FDA) Division of Dermatology and Dental Products has set a Prescription Drug User Fee Act (PDUFA) date of July 8 2019.

This essentially means that a Priority Review has been granted for SCENESSE on July 8, which could lead to the drug going on sale in the United States in the near future if it can satisfy its requirements.

The company’s chief scientific officer, Dr Dennis Wright was pleased with the news.

He said: “Acceptance of this NDA is the result of patience and hard work from the CLINUVEL team and medical community, bringing us a significant step closer to making SCENESSE available for US EPP patients,”

He added: “We are pleased with the work of the FDA to date and, contrary to our own expectations, the agency has stated that it does not intend to hold an advisory committee meeting for further review of the product.”

The company advised that it will now work towards a positive and landmark outcome for EPP patients on July 8.

Should you invest?

This is a very positive development for the company and I can’t say I’m surprised to see its shares take off today.

The U.S. market represents a major market for SCENESSE and could generate significant revenue for the company.

But with its valuation now ~$1 billion, I think CLINUVEL’s shares are fully valued and would suggest investors look elsewhere at the likes of CSL Limited (ASX: CSL) and Mayne Pharma Group Ltd (ASX: MYX).

Motley Fool contributor James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

FREE REPORT: Five Cheap and Good Stocks to Buy now…

Our Motley Fool experts have FREE report, detailing 5 dirt cheap shares that you can buy today.

One stock is an Australian internet darling with a rock solid reputation and an exciting new business line that promises years (or even decades) of growth… while trading at an ultra-low price…

Another is a diversified conglomerate trading near a 52-week low all while offering a 2.7% fully franked yield…

Plus 3 more cheap bets that could position you to profit over the next 12 months!

See for yourself now. Simply click the link below to scoop up your FREE copy and discover all 5 shares. But you will want to hurry – this free report is available for a brief time only.