- Two presentations highlighting data on DaxibotulinumtoxinA for
Injection, including one oral presentation showcasing new data on
clinical immunogenicity from the SAKURA Phase 3 program, and one
abstract on injection technique for midface volumization with
hyaluronic acid based fillers -
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology
company focused on innovative aesthetic and therapeutic offerings,
today announced two oral presentations and one ePoster at the
American Society for Dermatologic Surgery (ASDS) Virtual Annual
Meeting, November 19-21, 2021.
“We look forward to sharing a breadth of data at this year’s
ASDS Virtual Annual Meeting, including new data on
DaxibotulinumtoxinA for Injection in glabellar lines and a novel
injection technique for midface volumization with hyaluronic acid
fillers,” said Roman Rubio, Senior Vice President of Clinical
Development at Revance. “These presentations further demonstrate
our commitment to setting the new standard in facial aesthetic
treatments, advancing innovation in the category, while supporting
the strong growth potential of our pipeline.”
The first oral presentation will report on new data from the
SAKURA Phase 3 trials evaluating the immunogenic potential of
DaxibotulinumtoxinA for Injection in the treatment of glabellar
lines, with repeated drug administration. A second oral
presentation presents a new pooled responder analysis from the
SAKURA 1 and 2 glabellar lines studies and introduces a novel
method of visualizing the results.
An e-poster presents an optimized injection technique for
midface volumization, appropriate for dynamic Hyaluronic Acid based
fillers.
Oral Presentations:
- Title: Clinical Immunogenicity of DaxibotulinumtoxinA
for Injection in Glabellar Lines Including Subjects With Multiple
Exposures: Pooled Data from the SAKURA Phase 3 Trials Authors
and Affiliations: Shannon Humphrey, University of British
Columbia and Humphrey Cosmetic Dermatology, Vancouver, British
Columbia, Canada; Jeffrey S. Dover, SkinCare Physicians, Chestnut
Hill, MA; Ronald R. Bowsher, Amanda Clancy, B2S Life Sciences,
Franklin, IN; Yan Liu, Conor J. Gallagher, Revance Therapeutics,
Inc., Nashville, TN
- Title: Visualizing the Elimination of Glabellar Lines
Following Treatment With DaxibotulinumtoxinA for Injection
Authors and Affiliations: Shannon Humphrey, University of
British Columbia and Humphrey Cosmetic Dermatology, Vancouver,
British Columbia, Canada; Sabrina Fabi, Cosmetic Laser Dermatology,
San Diego, CA; Derek Jones, Skin Care and Laser Physicians of
Beverly Hills, Beverly Hills, CA; Todd Gross, Yan Liu, Roman Rubio,
Revance Therapeutics, Inc., Nashville, TN
e-Poster:
- Title: Midface volumization: A multilayering injection
technique for soft tissue hyaluronic acid fillers designed for
dynamic facial movement Authors and Affiliations: Hassan
Galadari, College of Medicine and Health Sciences, United Arab
Emirates University, Al Ain, UAE; Susan H. Weinkle, Private
practice, Bradenton, FL and University of South Florida, Tampa, FL;
Jay Mashburn, Revance Therapeutics, Inc., Nashville, TN
The above presentations will be live for the duration of the
ASDS virtual conference and also available on-demand for 60 days
post-meeting. Complete abstracts, details on presentation times and
changes to dates can be found on the ASDS website. Please check
www.asds.net for the latest information.
About Revance
Revance is a biotechnology company focused on innovative
aesthetic and therapeutic offerings, including its next-generation
neuromodulator product, DaxibotulinumtoxinA for Injection.
DaxibotulinumtoxinA for Injection combines a proprietary
stabilizing peptide excipient with a highly purified botulinum
toxin that does not contain human or animal-based components.
Revance has successfully completed a Phase 3 program for
DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is
pursuing U.S. regulatory approval. Revance is also evaluating
DaxibotulinumtoxinA for Injection in the full upper face, including
glabellar lines, forehead lines and crow's feet, as well as in two
therapeutic indications - cervical dystonia and adult upper limb
spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance
owns a unique portfolio of premium products and services for U.S.
aesthetics practices, including the exclusive U.S. distribution
rights to the RHA® Collection of dermal fillers, the first and only
range of FDA-approved fillers for correction of dynamic facial
wrinkles and folds, and the OPUL™ Relational Commerce platform.
Revance has also partnered with Viatris (formerly Mylan N.V.) to
develop a biosimilar to BOTOX®, which would compete in the existing
short-acting neuromodulator marketplace. Revance is dedicated to
making a difference by transforming patient experiences. For more
information or to join our team visit us at www.revance.com.
“Revance Therapeutics” and the Revance logo are registered
trademarks of Revance Therapeutics, Inc. Resilient Hyaluronic Acid®
and RHA® are trademarks of TEOXANE SA. BOTOX® is a registered
trademark of Allergan, Inc.
Forward-Looking Statements
Any statements in this press release that are not statements of
historical fact, including statements related to novel injection
technique; our ability to set a new standard in facial aesthetic
treatments; innovation in facial aesthetic treatments; our product
pipeline growth; the potential benefits of DaxibotulinumtoxinA for
Injection and the RHA® Collection of dermal fillers;
differentiation of our products; development of a biosimilar to
BOTOX®; and statements about our business strategy, timeline and
other goals, plans and prospects, constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. You should not rely upon forward-looking statements as
predictions of future events. Although we believe that the
expectations reflected in the forward-looking statements are
reasonable, we cannot guarantee that the future results, levels of
activity, performance, events, circumstances or achievements
reflected in the forward-looking statements will ever be achieved
or occur.
Forward-looking statements are subject to risks and
uncertainties that could cause actual results to differ materially
from our expectations. These risks and uncertainties relate, but
are not limited to: the results, timing, costs, and completion of
our research and development activities and regulatory approvals,
including our ability to obtain a Type A meeting with the FDA,
remediate deficiencies identified by the FDA, obtain FDA approval
of the BLA for DaxibotulinumtoxinA for Injection for the treatment
of glabellar lines, including as a result of observations made by
the FDA during the site inspection or other reasons; the timing of
capital expenditures; the impact of the COVID-19 pandemic on our
manufacturing operations, supply chain, end user demand for our
products and services, the aesthetics market, commercialization
efforts, business operations, regulatory meetings and approvals,
clinical trials and other aspects of our business and on the
market; our ability and the ability of our partners to manufacture
supplies for our product candidates and to acquire supplies of the
RHA® Collection of dermal fillers; the uncertain clinical
development process; the risk that clinical trials may not have an
effective design or generate positive results or that positive
results would assure regulatory approval or commercial success; the
applicability of clinical study results to actual outcomes; the
rate and degree of economic benefit, safety, efficacy, commercial
acceptance, market, competition and/or size and growth potential of
the RHA® Collection of dermal fillers, OPUL™ and our drug product
candidates, if approved; our ability to continue to successfully
commercialize the RHA® Collection of dermal fillers and OPUL™ and
our ability to successfully commercialize DaxibotulinumtoxinA for
Injection, if approved, and the timing and cost of
commercialization activities; the proper training and
administration of our products by physicians and medical staff; our
ability to expand sales and marketing capabilities; the status of
commercial collaborations; changes in and failures to comply with
privacy and data protection laws; our ability to effectively manage
our expanded operations in connection with the acquisition of Hint,
Inc; the profitability of and our ability to scale OPUL™, our
ability to transfer practices from HintMD to OPUL™, the features
and functionalities and benefits to practices and patients of
OPUL™; interruptions or performance problems associated with HintMD
or OPUL™; our ability to obtain funding for our operations; our
ability to continue obtaining and maintaining intellectual property
protection for our drug product candidates; the accuracy of our
estimates regarding expenses, future revenues, capital
requirements, our financial performance and the economics of
DaxibotulinumtoxinA for Injection, the RHA® Collection of dermal
fillers and OPUL™; the cost and our ability to defend ourselves in
product liability, intellectual property, class action or other
lawsuits; the volatility of our stock price; 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 our periodic
filings with the Securities and Exchange Commission (SEC),
including factors described in the section entitled "Risks Factors"
on our Form 10-K filed with the SEC on February 25, 2021 and
including, without limitation, our Form 10-Q for the quarter ended
September 30, 2021, expected to be filed with the SEC on November
9, 2021. The forward-looking statements in this press release speak
only as of the date hereof. We disclaim any obligation to update
these forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20211119005265/en/
Media Revance Therapeutics, Inc.: Sara Fahy, 949-887-4476
sfahy@revance.com
Investors Revance Therapeutics, Inc.: Jessica Serra,
626-589-1007 Jessica.serra@revance.com
or
Gilmartin Group, LLC.: Laurence Watts, 619-916-7620
laurence@gilmartinir.com
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