BELMONT Phase 2 Clinical Data to be Presented at IMCAS World Congress 2017
27 January 2017 - 8:05AM
Business Wire
- Poster Abstract at TOXINS 2017 Receives
Honors -
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology
company developing botulinum toxin products for use in aesthetic
and therapeutic indications, today announced presentation of
clinical data from the company’s BELMONT Phase 2 study of
DaxibotulinumtoxinA Injectable (RT002) at the 19th annual IMCAS
(International Master Course on Aging Skin) World Congress, taking
place at Palais des Congrès, Paris, France, January 26-29, 2017.
BELMONT was the company’s Phase 2 active comparator,
placebo-controlled, multi-center study to evaluate the safety,
efficacy, and duration of effect of RT002 injectable for the
treatment of glabellar (frown) lines.
Scheduled data presentation at IMCAS World Congress 2017:
Podium Presentation: "Outcome Assessment of Glabellar
Line Severity Grade in the BELMONT Study”, January 29, 11:30 am,
New Tech: R&D, Focus Session 201 – Room 6
Vince Bertucci, MD, Division of Dermatology, University of
Toronto, Toronto, ON, Canada, will present final data from the
BELMONT Phase 2 active comparator and placebo-controlled study of
RT002 injectable for the treatment of moderate to severe glabellar
(frown) lines in adults.
“The BELMONT study delivered compelling data demonstrating
increased subject response rates and extended duration of effect
from RT002 when compared to the market leading, short-acting
neurotoxin,” said Dan Browne, President and Chief Executive Officer
at Revance. “We drew heavily from the BELMONT study results and
discussions with the regulatory authorities to design the protocol
and endpoints for our SAKURA Phase 3 pivotal trials, which are
actively enrolling today and are expected to readout later this
year.”
In other medical conference news, Revance announced honors
received at the TOXINS 2017 international conference (Madrid,
Spain, January 18-21, 2017). On January 21, lead author Dr. Cynthia
L. Comella, Professor in the Department of Neurological Sciences at
Rush University Medical Center, Chicago, Illinois, was awarded best
clinical poster abstract for reporting results from Revance’s Phase
2 open-label, dose-escalating study to evaluate the safety and
preliminary efficacy of RT002 injectable in isolated cervical
dystonia, results which she also presented at podium.
About Revance Therapeutics, Inc.
Revance, a Silicon Valley-based biotechnology company, is
committed to the advancement of remarkable science. The company is
developing a portfolio of products for aesthetic medicine and
underserved therapeutic specialties, including dermatology,
orthopedics and neurology. Revance’s science is based upon a
proprietary peptide technology, which when combined with active
drug molecules, may help address current unmet needs. Revance’s
initial focus is on developing daxibotulinumtoxinA, the company’s
highly purified botulinum toxin, for a broad spectrum of aesthetic
and therapeutic indications, including facial wrinkles and muscle
movement disorders.
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 neurotoxin. The company holds
worldwide rights for all indications of RT002 injectable and RT001
topical and the pharmaceutical uses of its proprietary peptide
technology platform. 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 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 risks that interim results are
not indicative of final results and 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 4, 2016. 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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version on businesswire.com: http://www.businesswire.com/news/home/20170126006029/en/
Investors:Revance Therapeutics, Inc.Jeanie Herbert,
714-325-3584jherbert@revance.comorBurns McClellanAmi Bavishi,
212-213-0006abavishi@burnsmc.comorTrade Media:Nadine Tosk,
504-453-8344nadinepr@gmail.com
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