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Biotech Stocks Facing FDA Decision In November 2020

Revance
Revance

Revance Therapeutics Inc.’s (RVNC) next-generation neuromodulator product, DaxibotulinumtoxinA, or DAXI in short, awaits the FDA decision on November 25, 2020.

DAXI is proposed for the treatment of moderate to severe glabellar (frown) lines.

The Biologics License Application for DAXI was submitted to the FDA based on encouraging results from three phase III trials - SAKURA 1, 2, 3 - the largest aesthetic neuromodulator clinical program ever conducted for the treatment of glabellar lines.

DaxibotulinumtoxinA combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based component.

The U.S. neuromodulator market is estimated to be worth $1.4 billion. Botox, Dysport, Xeomin, and Jeuveau are the currently available approved neuromodulators for cosmetic use.

While the effects of the market leader Botox usually lasts for 3 to 6 months, DAXI is said to have long-lasting results, say at least 8 weeks longer than Botox, according to dermatologist Dr. Shannon Humphrey.

RVNC closed Friday’s (Oct.23, 2020) trading at $25.29, up 5.82%.