Revance Receives FDA Acceptance of BLA Resubmission for DaxibotulinumtoxinA for Glabellar Lines

Revance Therapeutics, Inc. RVNC announced acceptance of Biologics License Application (BLA) by the U.S. Food and Drug Administration (FDA) of its drug candidate DaxibotulinumtoxinA for Injection for the treatment of patients with moderate to severe glabellar lines. The regulatory agency has set a target action date of September 8, 2022.

The FDA designated the BLA as a Class 2 resubmission, which has a six-month review period and includes a required reinspection of the company's manufacturing facility.

The resubmission was followed by the Type A meeting in December 2021.

Revance Therapeutics shares trading down 3 percent at $16.89 during after hours.