Pivotal SAKURA Phase 3 Clinical Data to be Presented at IMCAS World Congress 2018
February 01 2018 - 4:05PM
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.
Forward-Looking Statements
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.
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INVESTORSRevance Therapeutics, Inc.:Jeanie Herbert,
714-325-3584jherbert@revance.comorBurns McClellan, Inc.:Ami
Bavishi, 212-213-0006abavishi@burnsmc.comorMEDIAGeneral
Media:TOGORUN:Mariann Caprino,
917-242-1087m.caprino@togorun.comorTrade Media:Nadine Tosk,
504-453-8344nadinepr@gmail.com
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