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Revance Provides Regulatory Update on DaxibotulinumtoxinA for Injection for the Treatment of Moderate to Severe Glabellar (Frown) Lines

October 15, 2021 5:10 PM EDT

NASHVILLE, Tenn.--(BUSINESS WIRE)-- Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the United States (U.S.) Food and Drug Administration (FDA) has issued a Complete Response Letter, or CRL, regarding the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection, for the treatment of moderate to severe glabellar (frown) lines.

In a communication received on October 15, the FDA has determined it is unable to approve the BLA in its present form, and indicated that there are deficiencies related to the FDAs... More