Revance Therapeutics' frown-line injection, Daxxify, gained U.S. approval on Monday to treat an involuntary movement disorder, and RVNC stock rose.
Specifically, the Food and Drug Administration signed off on Daxxify for patients with cervical dystonia, a painful condition in which neck muscles contract involuntarily. This can cause the head to twist or turn to the side.
The approval takes a page from AbbVie's playbook for Botox. Botox is a well-known treatment for frown lines and wrinkles. But it's also used for a myriad medical conditions like migraines and excessive sweating. This is Daxxify's first approval outside of its role as an aesthetic treatment.
"We are very pleased to see the expansion of the Daxxify label to include our first therapeutic indication, unlocking a new market opportunity for Daxxify following the product's recent launch in the aesthetics market," Chief Executive Mark Foley said in a written statement. "Further, we believe FDA approval represents a significant advancement in the treatment of cervical dystonia."
On the stock market today, RVNC stock jumped 2.9% to close at 19.46, paring back bigger premarket gains.
RVNC Stock: Following AbbVie's Playbook
Like Botox, Daxxify is a neuromodulator. Neuromodulators interrupt the signals between the nerves and muscles, preventing the muscles in a specific area from contracting.
The mechanism is paying off for both aesthetic and therapeutic uses. Last year, Botox generated $2.62 billion from cosmetic treatments. As a therapeutic drug, Botox brought in $2.72 billion in sales.
Daxxify is a newer entrant to the market. On Sept. 8, the day it gained approval as an aesthetic treatment, RVNC stock rocketed almost 22%. The company fully launched Daxxify earlier this year. Now, Revance says the therapeutic neuromodulator market is worth $2.5 billion in the U.S.
Revance is first planning on a soft launch of Daxxify to physicians treating cervical dystonia, before a full commercial launch in early 2024.
The news Monday helped RVNC stock dig out of three days in the red. Still, shares have a poor Relative Strength Rating of 8 out of a best-possible 99, according to IBD Digital. This puts Revance stock in the bottom 8% of all stocks when it comes to 12-month performance.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
