Shares of Revance Therapeutics Inc. rose more than 10% in premarket trading Wednesday after the biotechnology company said it still expects U.S. Food and Drug Administration approval of its injection treatment for frown lines by the end of the year.
Revance shares tumbled 25% on Tuesday after the FDA, responding to a Freedom of Information Act request, released a document outlining concerns raised by a pre-approval inspection of the company's manufacturing plant in late June and early July.
The FDA early last year accepted Revance's application for DaxibotulinumtoxinA for Injection, or DAXI, with a decision expected before the end of the year. However, the agency deferred its decision because it hadn't been able to inspect the California manufacturing plant due to travel restrictions related to the Covid-19 pandemic.
Revance late Tuesday said the issuance of the FDA document, known as a Form 483, following an inspection isn't uncommon and doesn't constitute a final determination. The Newark, Calif., company said it responded to the Form 483 in July, and that its application remains under FDA review.
Several Wall Street analysts reiterated positive recommendations for Revance shares, noting that while the Form 483 could raise some worries about DAXI's approval, the document is heavily redacted, making the FDA's observations difficult to interpret.
Analysts at Piper Sandler, noting Revance's comment that it still expects a green light by the end of the year, said they give the company the benefit of the doubt and reiterated an overweight stance and $37 a share price target.
Wells Fargo, with a $35 price target on the stock, said Tuesday's selloff made the Revance risk/reward more favorable and reiterated an overweight recommendation.
