Longer-lasting Botox competitor nabs FDA approval — can it compete with AbbVie's $2B cash cow?
Revance Therapeutics announced Thursday that its first FDA approval has finally arrived for its Botox competitor, known as Daxxify, after initially submitting its original BLA way back in January 2020.
The botulinum toxin products will compete to temporarily improve moderate to severe frown lines, and for what Revance estimates is a $3.2 billion and growing market.
Revance is looking to corner a slice of that market with its longer-lasting, potentially twice-yearly injection, whereas those using Botox may have to return for more injections every three to four months. Wall Street biotech analysts previously indicated that this difference may be key for Revance in doing better than other previously launched Botox knock-offs.
The Daxxify approval was based on a Phase III clinical trial program including more than 2,700 participants and follows about 20 years of market dominance for Botox. Evolus scored an FDA approval for a rival in 2019, known as Jeuveau, but only mustered 2021 sales of almost $100 million, just a fraction of the $2.2 billion revenue AbbVie reported for Botox.
Revance CEO Mark Foley said on an investor call this morning that Daxxify will disrupt this market because of its longer duration in helping with facial lines.
Shares of Revance $RVNC stock were up more than 16% in premarket trading Thursday. The company did not disclose the new injection’s list price.
But the company’s nearly three-year odyssey at the FDA did include one rejection letter, issued in October 2021, after the agency uncovered numerous problems with the biotech’s manufacturing site.
The “actual yield” and “theoretical yield” figures didn’t entirely add up, the FDA said, and the manufacturing process they found was different from the one proposed by Revance for commercialization.