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).
