Shares of Evolus Inc (NASDAQ:EOLS) shot up Monday in pre-market trading after the Food and Drug Administration approved the company's new wrinkle treatment for adult patients, which is expected to be a key rival to Allergan's PLC’s (NYSE:AGN) Botox.
The stock soared 21.1% to $22.20 before the opening bell.
The Irvine, California-based medical aesthetic company said that Jeuveau is expected to be available throughout the US starting in spring 2019.
“Evolus is the first company in nearly a decade to enter the fast-growing US aesthetic neurotoxin market,” said Evolus CEO David Moatazedi. “What makes Evolus unique is our focus on delivering performance beauty products with a customer-centric approach.”
The safety and efficacy of Jeuveau has been evaluated in clinical studies with over 2,100 patients.
“The outcomes I’ve seen for my clinical trial patients first hand, combined with the comprehensive clinical data set for Jeuveau provide a compelling new treatment option for physicians and their aesthetic patients,” said board-certified dermatologist and clinical investigator Ava Shamban in a statement.
The FDA approval came late Friday, after Evolus announced in August last year that Health Canada gave it marketing approval to sell its Botox-like treatment for frown lines.
Evolus said at the time that it was marketing its product in Canada through its partner Clarion Medical Technologies Inc to Canadian hospitals, aesthetic clinics and private medical practices.
Jeuveau (prabotulinumtoxinA-xvfs) is a proprietary 900 kDa purified botulinum toxin type A formulation found to temporarily improve the appearance of moderate to severe glabellar lines, or deep frown lines.
The company earlier said it plans to price the treatment at a discount of betwween 20% and 25% to Allergan's Botox, which generated $3.5 billion in sales last year for the Dublin, Ireland-based pharmaceutical group.
Contact Uttara Choudhury at [email protected]