Revance Therapeutics Inc (RVNC)

[floblu14]

A 2nd positive news release today. Is approval next?

Revance to Showcase Clinical Findings at The Aesthetic Meeting 2021 that Supports DaxibotulinumtoxinA’s 24-Week Long Duration Profile Across Multiple Female Age Cohorts
April 27, 2021

NASHVILLE, Tenn.--(BUSINESS WIRE)--Apr. 27, 2021-- Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced an upcoming presentation at The American Society for Aesthetic Plastic Surgery (ASAPS) Aesthetic Meeting 2021, being held at The Miami Beach Convention Center in Miami Beach, FL from April 29 – May 3, 2021. The video presentation will include data from a subgroup analysis from the Phase 3 SAKURA clinical program demonstrating the efficacy, duration, and safety of DaxibotulinumtoxinA for Injection in adult females across multiple age cohorts following the treatment of glabellar lines.

DaxibotulinumtoxinA for Injection is a novel botulinum toxin type A for which Revance is currently seeking FDA approval for the treatment of glabellar lines (GL). It is generally accepted that as age increases, the efficacy of botulinum toxin decreases. This has been demonstrated in multiple studies with current aesthetic botulinum toxin products. The subgroup analysis from the Phase 3 SAKURA clinical program for glabellar lines (GL), which is the largest program for GL with over 3,000 subjects, examined the effects of DaxibotulinumtoxinA for Injection on GL among female subjects ages: 18-45, >45-55, and >55. A further analysis was performed on female subjects <65 and ≥65 years. The data from the analysis showed that DaxibotulinumtoxinA for Injection was safe, effective and delivered a median time to loss of none or mild of at least 24 weeks across all female age groups.

“We look forward to sharing the positive results from our Phase 3 SAKURA program at this year’s Aesthetic Meeting,” said Roman Rubio, Senior Vice President of Clinical Development at Revance. “The data demonstrates DaxibotulinumtoxinA for Injection’s 24-week duration independent of age in women, in addition to its positive efficacy and safety endpoints in each subgroup analysed.”

The abstracts are available online via the ASAPS website at surgery.org.

Video Presentation:

Title: DaxibotulinumtoxinA for Injection Demonstrates Consistent Efficacy, Duration, and Safety in Females Independent of Age: Subgroup Analysis from a Large, Phase 3 Program (SAKURA)
Authors and Affiliations: Glynis Ablon, Ava Shamban, Susan Weinkle, Jessica Brown, Yan Liu, Ablon Skin Institute, Manhattan Beach, CA; Ava MD, Santa Monica & Beverly Hills, CA; Susan H. Weinkle, MD, Bradenton, FL; Revance Therapeutics, Newark, CA

https://investors.revance.com/news-releases/news-release-details/revance-showcase-clinical-findings-aesthetic-meeting-2021