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Biotech Stocks Facing FDA Decision In September

Revance Therapeutics
Revance Therapeutics

Revance Therapeutics Inc.’s (RVNC) DaxibotulinumtoxinA, proposed for the treatment of moderate to severe glabellar (frown) lines, is at the FDA altar for the second time, with a decision expected on September 8.

The U.S. regulatory agency had declined to approve DaxibotulinumtoxinA last October citing deficiencies in the company’s manufacturing facility.

After addressing the concerns raised by the FDA, the company resubmitted the Biologics License Application to the FDA for DaxibotulinumtoxinA on March 8, 2022, and now awaits the decision.

DaxibotulinumtoxinA, if approved, will have to compete with AbbVie’s Botox Cosmetic, Ipsen’s Dysport, Merz Pharma’s Xeomin, and Evolus’ Jeuveau.

RVNC closed Friday’s trading at $19.44, down 6.27%.