The CLINUVEL Pharmaceuticals Limited (ASX: CUV) share price has pushed higher on Wednesday after it provided an update on its SCENESSE product.
In late morning trade the shares of the skin disorder-focused global biopharmaceutical company are up 2.5% to $25.38.
What did CLINUVEL announce?
This morning CLINUVEL provided an update on its dealings with the US Food and Drug Administration (FDA).
The company has been waiting for some time for the FDA to review SCENESSE so that it can then potentially go on sale in the massive market.
At the end of May the U.S. regulator set a new goal date of October 6 2019 for its review to allow time to evaluate data provided by CLINUVEL as part of the scientific exchange within the review process.
With that date now approaching, CLINUVEL released an update on where things stand.
According to today's release, the FDA has notified the company that the Prescription Drug User Fee Act goal date for review of the submission of the SCENESSE scientific dossier had been miscommunicated by the agency.
But thankfully, the miscommunication wasn't overly material. Instead of October 6, the date has been confirmed as October 8. Which means this time next week the company may finally have a decision.
CLINUVEL's Chief Scientific Officer, Dr Dennis Wright said: "Our team continues to engage with the FDA at this late stage to address final questions and clarifications on the dossier. While it may be frustrating for all who take an active interest in our programs, nothing materially has changed in our outlook and we will continue our diligent approach in the coming days to seek a positive outcome."
Judging by the share price rise today, some investors appear hopeful that SCENESSE will be given the tick of approval by the FDA. At present SCENESSE (afamelanotide16mg) is approved in Europe as an orphan medicinal product for the prevention of phototoxicity in adult patients with EPP.
Also on the rise today in the healthcare sector are the shares of Mayne Pharma Group Ltd (ASX: MYX) and Resapp Health Ltd (ASX: RAP) after positive updates.
