NEWARK, Calif.--(BUSINESS WIRE)--Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company developing neuromodulators for use in treating aesthetic and therapeutic conditions, today announced oral and ePoster presentations of clinical data from the company’s two pivotal SAKURA Phase 3 trials of DaxibotulinumtoxinA Injectable (RT002) at The Aesthetic Meeting 2018, organized by the American Society of Aesthetic Plastic Surgery (ASAPS) and taking place at the Jacob K. Javits Convention Center, New York, New York, April 26-May 1, 2018. The company’s SAKURA Phase 3 clinical program included two randomized, double-blind, placebo-controlled pivotal trials to evaluate the safety and efficacy of a single administration of RT002 for the treatment of moderate-to-severe glabellar lines in 609 adults.
Scheduled presentations at the 2018 American Society of Aesthetic Plastic Surgery Meeting:
Oral Presentation: SAKURA 1 and 2 Phase 3 Pivotal Studies DaxibotulinumtoxinA for Injection (RT002) for the Treatment of Moderate to Severe Glabellar Lines will be delivered during the Premier Global Hot Topics session by Brian S. Biesman, M.D., F.A.C.S., Clinical Assistant Professor at Vanderbilt University School of Medicine, in Nashville, Tennessee. Dr. Biesman will present top-line results from the pivotal SAKURA Phase 3 trials of RT002 injectable for the treatment of moderate-to-severe glabellar lines in adults. These results were first released on December 5, 2017. Dr. Biesman also will participate in a panel discussion following his presentation entitled “What’s the Difference and Why Should I Start Using a New Toxin?”
ePoster Presentation: Duration of Effect in Two Phase 3, Randomized, Double-Blind, Placebo Controlled, Multi-Center Trials Evaluating Safety & Efficacy of DaxibotulinumtoxinA for Injection Treating Moderate to Severe Glabellar Lines (SAKURA 1 & 2). Dr. Arthur Swift, M.D., C.M., F.R.C.S.(C), Westmount Institute of Plastic Surgery in Westmount, Québec, Canada is the lead author of the ePoster, which will feature the top-line results from the pivotal SAKURA Phase 3 trials.
“We are very pleased that the compelling data from our SAKURA trials will be highlighted by key luminaries at a leading U.S. plastic surgery conference, including highly statistically significant results for RT002 and its differentiated long-acting 6-month performance,” said Dan Browne, President and Chief Executive Officer at Revance. “As previously announced, SAKURA 3, our final, long-term safety study in this program has been fully enrolled. We anticipate completion of this trial in the second half of this year, followed by our regulatory filing for RT002 to treat glabellar lines in the first half of 2019.”
About Revance Therapeutics, Inc.
Revance Therapeutics is a biotechnology company developing neuromodulators for use in treating aesthetic and underserved therapeutic conditions, including muscle movement disorders and pain. The company's lead drug candidate, DaxibotulinumtoxinA for Injection (RT002), is currently in development for the treatment of glabellar lines, cervical dystonia and plantar fasciitis, with plans to initiate studies in upper limb spasticity and chronic migraine. RT002 has the potential to be the first long-acting neuromodulator. Revance has developed a proprietary, stabilizing excipient peptide technology designed to create novel, differentiated therapies. The company has a comprehensive pipeline based upon its peptide technology, including injectable and topical formulations of daxibotulinumtoxinA. More information on Revance may be found at www.revance.com.
“Revance Therapeutics” and the Revance logo are registered trademarks of Revance Therapeutics, Inc.
This press release contains forward-looking statements, including statements related to Revance Therapeutics' 2018 Financial Outlook and other financial performance, the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational drug product candidates, including but not limited to initiation and design of clinical studies for current and future indications, related results and reporting of such results; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects; and statements about our ability to obtain regulatory approval; and potential benefits of our drug product candidates and our technologies.
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; our ability to successfully commercialize our drug product candidates and the timing of commercialization activities; the rate and degree of market acceptance of our drug product candidates; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Revance's periodic filings with the Securities and Exchange Commission (the "SEC"), including factors described in the section entitled "Risk Factors" of our annual report on Form 10-K filed March 2, 2018. These forward-looking statements speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.