Shares of Revance Therapeutics (NASDAQ:RVNC) are up by a respectable 15.8% as of 11:08 a.m. EDT Wednesday morning. The biopharma’s stock is regaining some of its lost ground after yesterday’s unfortunate 22% dip.
Shares of Revance hit the skids yesterday following the public disclosure of a Form 483 stemming from a Freedom of Information Act request directed at the U.S. Food and Drug Administration (FDA). This regulatory form noted issues with the company’s manufacturing process for DaxibotulinumtoxinA injection, an experimental treatment for glabellar lines. Glabellar lines are the lines on your forehead that can deepen with age.
Revance’s stock is rebounding today due to management’s response to this public disclosure. The long and short of it is that these types of regulatory steps — and notices — are common during the regulatory review cycle for a pharmaceutical product. Revance’s management informed investors of this fact in their press release on the matter.
Investors, for their part, seem to be reassured to some degree by this proactive step. Perhaps even more importantly, the company also said that the Biologics License Application for DaxibotulinumtoxinA is still under review with the FDA, and the company anticipates that the drug will ultimately be approved before the year’s end. An approval is not guaranteed, of course. But management at least seems confident in the prospects of this regulatory filing.
The big deal is that this cosmetic drug candidate is expected to eventually rake in sales in excess of $1 billion per year. That’s a sizable revenue stream for a company with a market cap of $1.65 billion at the time of writing. Additionally, this drug may dramatically boost Revance’s value as a potential takeover candidate. In short, investors comfortable with risk may want to consider buying shares of the pharma company ahead of DaxibotulinumtoxinA’s regulatory decision later this year.
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