Reuters- Revance Therapeutics Inc said on Friday that the U.S. Food and Drug Administration had declined to approve its long-acting injectable drug to treat moderate to severe frown lines, sending its shares plunging 29%.
The company pointed to deficiencies related to the FDA inspection of Revance manufacturing site.
The drug developer said no other concerns were raised in the complete response letter of the agency's agency.
AbbVie Inc's DaxibotulinumtoxinA for Injection, a potential competitor for Revance's DaxibotulinumtoxinA for Injection, was successful in reducing moderate to severe frown lines in a late-stage study in December 2018.
In November last year, the U.S. FDA delayed its decision on the drug, as it was unable to conduct required inspection of the company's manufacturing facility due to COVID - 19 travel restrictions. Revance later said that it would expect approval in 2021.
We are very disappointed by the response of the FDA and want further clarity from the agency, said Mark Foley, chief executive officer of Revance, in a statement on Friday.
Revance said it plans to contact FDA as soon as possible to address the agency's concerns.
The shares of the company, which closed on Friday at $22.71 were sold in extended trade to $26.20.