Revance Announces Ground-Breaking Data Presentations at Leading International Neurotoxin Conference
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company developing next-generation neuromodulators for use in treating aesthetic and therapeutic conditions, today announced 11 clinical and non-clinical presentations for DaxibotulinumtoxinA for Injection (RT002) and the company’s unique proprietary peptide and formulation technology at TOXINS 2019, a leading international conference on neurotoxins to be held Jan. 16 through 19 in Copenhagen, Denmark.
"We will have a significant presence at the bi-annual TOXINS 2019, which attracts scientific and clinical experts from around the world who are specifically focused on the basic science and clinical applications of neurotoxins," said Dan Browne, president and chief executive officer at Revance. “Our 11 presentations will cover a variety of evidence-based clinical results for our lead product candidate RT002 in treating both glabellar (frown) lines and cervical dystonia, along with detailed examinations of our unique proprietary peptide and formulation technology. We’re excited to share data on the first new neuromodulator in more than 30 years that delivers high response rates and long-lasting results without compromising safety.”
Revance’s scheduled presentations are:
- Pooled Results from Two Phase 3 Pivotal Studies of DaxibotulinumtoxinA for the Treatment of Glabellar Lines (Jan. 17, 4:30 pm CET, Clinical Workshop 1B). Presenter: Dr. Steven G. Yoelin, Ophthalmologist at Steve Yoelin MD Medical Associates.
- Outcomes of Week-24 Completers and Subjects who had Follow-Up Beyond Week 24 after a Single Treatment of DaxibotulinumtoxinA; Results of a Phase 2 Open-Label Dose-Escalating Study in Isolated Cervical Dystonia (Jan. 18, 3:30 pm CET, Clinical Workshop 3A). Presenter: Dr. Atul Patel, Kansas City Bone & Joint Clinic.
Poster Presentations (Jan. 17 and 18, noon to 2:30 pm CET)
- Pooled Results from Two Phase 3 Pivotal Studies of DaxibotulinumtoxinA for the Treatment of Glabellar Lines
- Results of a Large Open-Label Safety Study of DaxibotulinumtoxinA in Glabellar Lines
- A Head-to-Head Dose-Ranging Study of DaxibotulinumtoxinA in the Treatment of Glabellar Lines: Results of the BELMONT Study
- Immunogenicity of DaxibotulinumtoxinA in Adults with Cervical Dystonia from a Phase 2 Dose-Escalation Multicenter Study
- Outcomes of Week-24 Completers and Subjects who had Follow-Up Beyond Week 24 after a Single Treatment of DaxibotulinumtoxinA: Results of a Phase 2 Open-Label, Dose-Escalating Study in Isolated Cervical Dystonia
- Methodology of a Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel group, Dose-Ranging 36-week Multicenter Trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for the Treatment of Upper Limb Spasticity in Adults after Stroke or Traumatic Brain Injury
- Revance's Novel Peptide Excipient (RTP004) and its Role in Stabilizing DaxibotulinumtoxinA against Aggregation
- Development of Cell-Based Potency Assay for Release and Stability Testing of Drug Substance and Drug Product
- Non-Clinical Overview of DaxibotulinumtoxinA to Support Registration for Human Use
- Novel Peptide Excipient RTP004 Enhances the Binding of Botulinum Neurotoxin, a Cell Binding Domain HC to Rat Brain Synaptosomes
- Stabilizing Effect of RTP004 on Non-Specific Surface Adsorption in Drug Product Manufacturing of DaxibotulinumtoxinA
About Revance Therapeutics, Inc.
Revance Therapeutics is an emerging Silicon Valley biotechnology leader developing neuromodulators for the treatment of aesthetic and therapeutic conditions. Revance uses a unique proprietary peptide excipient technology to create novel, differentiated therapies. The company’s lead compound, DaxibotulinumtoxinA for Injection (RT002), is in clinical development for a broad range of aesthetic and therapeutic indications, including glabellar lines, cervical dystonia, plantar fasciitis, upper limb spasticity and chronic migraine. RT002 has the potential to be the first long-acting neuromodulator. The company is advancing a robust pipeline of 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, expected cash burn 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, the initiation, design, timing and results of our clinical studies, including the SAKURA 3 study of RT002, ASPEN Phase 3 program, JUNIPER Phase 2 and other clinical programs relating to RT002 and related results and reporting of such results; results of our non-clinical programs; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects; including our pre-commercialization plans and timing of our potential BLA filing for RT002 to treat glabellar (frown) lines; and statements about our ability to obtain regulatory approval with respect to our drug; and potential benefits of our drug product candidates and our excipient peptide and other 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 quarterly report on Form 10-Q filed November 2, 2018. These forward-looking statements speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.
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