NEWARK, Calif.--(BUSINESS WIRE)--Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company developing neuromodulators for use in treating aesthetic and underserved therapeutic conditions, today announced presentation of clinical data from the company’s two pivotal SAKURA Phase 3 trials of DaxibotulinumtoxinA Injectable (RT002) at the 20th annual IMCAS (International Master Course on Aging Skin) World Congress, taking place at Palais des Congrès, Paris, France, February 1-3, 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 adults. The results were first reported on December 5, 2017.
Scheduled data presentation at IMCAS World Congress 2018:
Podium 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)”, February 3, 2018, 5:20 pm, R&D Focus Session S271,S272 - Room 10. Gary D. Monheit, MD, Clinical Professor, Department of Dermatology & Department of Ophthalmology, University of Alabama, Birmingham and Founding Dermatologist at Total Skin & Beauty Dermatology Center, 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.
“Our SAKURA trials delivered compelling, highly statistically significant results and a long-acting 6-months duration,” said Dan Browne, Co-Founder, President and Chief Executive Officer of Revance. “We are pleased that these data will be presented at the leading international conference in facial aesthetics, and we look forward to completing our long-term safety study – SAKURA 3 – in the second half of this year, which is needed for our regulatory filing of RT002 to treat glabellar lines, expected in 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 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 our business strategy, timeline and other goals and market for our anticipated products, plans and prospects; statements about our ability to obtain regulatory approval; and statements about 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; 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 quarterly report on Form 10-Q filed November 3, 2017. These forward-looking statements speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.