Revance Shares Shoot Higher As FDA Cleared DAXXIFY Injection For Frown Lines

The United States Food and Drug Administration (FDA) has approved Revance Therapeutics’ RVNC lead asset DAXXIFY (DaxibotulinumtoxinA-lanm) for injection for the temporary improvement of moderate to severecfrown lines (glabellar lines) in adults.

The regulatory approval was supported by the data generated in the SAKURA Phase 3 clinical trial program, which included more than 2,700 patients and approximately 4,200 treatments.

DAXXIFY is generally safe and well tolerated with no serious treatment-related adverse events reported in the clinical trials and has a safety profile consistent with other currently available neuromodulators in the aesthetics market.

The lead candidate, DAXXIFY (daxibotulinumtoxinA-lanm) for injection is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.

Mark J. Foley, Chief Executive Officer, commented: "The FDA approval of DAXXIFY is a foundational achievement for the company as it marks the culmination of years of pioneering research and development made possible by the outstanding execution of our talented team, along with strong support from the medical and investor communities. It has been an incredible and rewarding journey to realize our vision and bring this disruptive innovation to an industry that has remained largely unchanged for over 30 years.”

Price Action : Revance shares are trading higher 16 percent at $24.18 on Thursday during pre-market session.