Please ensure Javascript is enabled for purposes of website accessibility

The FDA Accepted Revance Therapeutics' Application for Approval Of Its Botox Competitor

By Todd Campbell - Feb 6, 2020 at 3:09PM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

The company's frown line treatment moved closer to commercialization today.

A new alternative to Allergan's (AGN) blockbuster aesthetics treatment Botox may be available by the end of 2020. On Thursday, Revance Therapeutics (RVNC 0.99%) announced the Food and Drug Administration (FDA) accepted its application for approval of DAXI (daxibotulinumtoxinA for injection), a long-lasting neurotoxin for use in treating frown lines.

A man in a suit climbs a pile of failure signs toward a finish line.

IMAGE SOURCE: GETTY IMAGES.

A clinical-stage biotech, Revance Therapeutics recently in-licensed U.S. marketing rights to TEOXANE SA's hyaluronic acid dermal fillers, which are used in aesthetic procedures. That accelerated the company's transition to a commercial-stage company, giving it an opportunity for revenue while it awaits an FDA go/no-go decision on DAXI. The company filed its application for DAXI's approval late last year.

The FDA is reviewing DAXI under its standard 10-month timeline, and DAXI's prescription drug user fee act (PDUFA) decision date has been set for Nov. 25, 2020. Regulators don't currently expect to convene an advisory committee meeting to debate DAXI's merits, a move that may suggest an easier pathway to an FDA green light.

If regulators cooperate, Revance Therapeutics plans to position DAXI as a longer-lasting alternative to Botox. In phase 3 clinical trials, DAXI helped reduce frown lines for a median 24 weeks. By comparison, Botox Cosmetic's efficacy lasts between three to four months.

Trials evaluating DAXI as a treatment for crow's feet and forehead lines are ongoing, with data expected by mid-year. Revance Therapeutics estimates the total facial aesthetics market is worth $2.2 billion annually.

 

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Revance Therapeutics, Inc. Stock Quote
Revance Therapeutics, Inc.
RVNC
$15.28 (0.99%) $0.15
Allergan plc Stock Quote
Allergan plc
AGN

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
336%
 
S&P 500 Returns
115%

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 06/26/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.