- Company completes End-of-Phase 2 Meeting with
FDA -
Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology
company developing botulinum toxin products for use in aesthetic
and therapeutic indications, today announced the completion of its
End-of-Phase 2 meeting with the U.S. Food and Drug Administration
(FDA) along with receipt of Scientific Advice from the Europe
Medicines Agency (EMA) regarding DaxibotulinumtoxinA for Injection
(RT002) for the treatment of cervical dystonia, a movement disorder
of the neck, in adults. Based on the Phase 2 safety and efficacy
results, along with guidance from the FDA and EMA, Revance plans to
proceed to a Phase 3 program in cervical dystonia.
Revance’s Phase 3 program will be conducted at multiple sites in
the U.S., Canada and Europe, and will be designed to fulfill
regulatory submission requirements in both the U.S. and Europe.
Revance is finalizing the trial protocols for the pivotal program,
which is planned to commence in the second quarter of 2018.
In May 2017, the company reported that in a Phase 2 trial, RT002
appeared to be generally safe and well-tolerated, delivered
clinically significant improvement in signs and symptoms of
cervical dystonia in patients, and demonstrated duration of effect
of at least 24 weeks. Earlier this month, the company announced
that the FDA granted Orphan Drug Designation for RT002 to treat
cervical dystonia.
“Our discussions with the FDA and EMA were very fruitful,
directing specific courses of action for our clinical program for
RT002 in cervical dystonia,” said Dan Browne, President and Chief
Executive Officer of Revance. “We are energized by the momentum
behind our first potential therapeutic indication and are excited
by the prospect of bringing this promising, long-acting therapy to
those suffering from this highly debilitating disease.”
About Cervical Dystonia
According to the Dystonia Medical Research Foundation, whose
mission is to advance research, promote awareness and education,
and support the needs of affected individuals, cervical dystonia is
a painful condition in which the neck muscles contract
involuntarily, causing abnormal movements and awkward posture of
the head and neck. The movements may be sustained (tonic), jerky
(clonic), or a combination. Cervical dystonia (also referred to as
spasmodic torticollis) may be primary (meaning that it is the only
apparent neurological disorder, with or without a family history)
or may be brought about by secondary causes (such as physical
trauma). It can result in considerable pain and discomfort.
Treatments for cervical dystonia include oral medications,
botulinum toxin injections, surgery, and complementary therapies.
Botulinum toxin can help block the communication between the nerve
and the muscle and may alleviate abnormal movements and postures.
Current botulinum toxin treatments for cervical dystonia have a
duration of effect of approximately three months. Cervical dystonia
can occur at any age, although most individuals first experience
symptoms in middle age. The condition affects a few hundred
thousand adults and children in the United States alone. Revance
estimates the global market for treating muscle movement disorders
with botulinum toxins, including cervical dystonia, was nearly $1
billion in 2015.
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 neuromodulator. The company
holds worldwide rights to 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 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 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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version on businesswire.com: http://www.businesswire.com/news/home/20171129006208/en/
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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