Revance to Showcase Clinical Findings at The Aesthetic Meeting 2021 that Supports DaxibotulinumtoxinA’s 24-Week Long Durati...
April 27 2021 - 4:05PM
Business Wire
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology
company focused on innovative aesthetic and therapeutic offerings,
today announced an upcoming presentation at The American Society
for Aesthetic Plastic Surgery (ASAPS) Aesthetic Meeting 2021, being
held at The Miami Beach Convention Center in Miami Beach, FL from
April 29 – May 3, 2021. The video presentation will include data
from a subgroup analysis from the Phase 3 SAKURA clinical program
demonstrating the efficacy, duration, and safety of
DaxibotulinumtoxinA for Injection in adult females across multiple
age cohorts following the treatment of glabellar lines.
DaxibotulinumtoxinA for Injection is a novel botulinum toxin
type A for which Revance is currently seeking FDA approval for the
treatment of glabellar lines (GL). It is generally accepted that as
age increases, the efficacy of botulinum toxin decreases. This has
been demonstrated in multiple studies with current aesthetic
botulinum toxin products. The subgroup analysis from the Phase 3
SAKURA clinical program for glabellar lines (GL), which is the
largest program for GL with over 3,000 subjects, examined the
effects of DaxibotulinumtoxinA for Injection on GL among female
subjects ages: 18-45, >45-55, and >55. A further analysis was
performed on female subjects <65 and ≥65 years. The data from
the analysis showed that DaxibotulinumtoxinA for Injection was
safe, effective and delivered a median time to loss of none or mild
of at least 24 weeks across all female age groups.
“We look forward to sharing the positive results from our Phase
3 SAKURA program at this year’s Aesthetic Meeting,” said Roman
Rubio, Senior Vice President of Clinical Development at Revance.
“The data demonstrates DaxibotulinumtoxinA for Injection’s 24-week
duration independent of age in women, in addition to its positive
efficacy and safety endpoints in each subgroup analysed.”
The abstracts are available online via the ASAPS website at
surgery.org.
Video Presentation:
- Title: DaxibotulinumtoxinA for Injection Demonstrates
Consistent Efficacy, Duration, and Safety in Females Independent of
Age: Subgroup Analysis from a Large, Phase 3 Program (SAKURA)
Authors and Affiliations: Glynis Ablon, Ava Shamban, Susan
Weinkle, Jessica Brown, Yan Liu, Ablon Skin Institute, Manhattan
Beach, CA; Ava MD, Santa Monica & Beverly Hills, CA; Susan H.
Weinkle, MD, Bradenton, FL; Revance Therapeutics, Newark, CA
About Revance Therapeutics, Inc.
Revance Therapeutics, Inc. 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 HintMD fintech platform, which includes
integrated smart payment, subscription and loyalty digital
services. 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 our ability to
obtain, and the timing relating to the anticipated approval of
DaxibotulinumtoxinA for Injection in glabellar lines; the results
of the SAKURA Phase 3 clinical program; development of a biosimilar
to BOTOX®; statements about our business strategy, timeline, other
goals and our plans and prospects; and potential benefits of our
drug product candidates and our technologies, 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 delays in the approval of our BLA for DaxibotulinumtoxinA
for Injection for the treatment of glabellar lines; the impact of
the COVID-19 pandemic on our manufacturing operations, supply
chain, end user demand for our products, commercialization efforts,
business operations, clinical trials and other aspects of our
business; our ability to manufacture supplies for our product
candidates; the uncertain clinical development process; the risk
that clinical trials may not have an effective design or generate
positive results; the applicability of clinical study results to
actual outcomes; our ability to successfully compete with other
treatments and therapies; our ability to achieve, and the rate and
degree of commercial acceptance and the market, size and growth
potential of our drug product candidates, if approved; our ability
to successfully commercialize our drug product candidates, if
approved, and the timing and cost of commercialization activities;
our ability to obtain and maintain regulatory approval of our drug
product candidates; unanticipated costs or delays in research,
development, and commercialization efforts; our ability to develop
sales and marketing capabilities; the status of commercial
collaborations; our ability to obtain funding for our operations;
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. 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/20210427005128/en/
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
Media Revance Therapeutics, Inc.: Sara Fahy, 949-887-4476
sfahy@revance.com or General Media: Goodfuse: Jenifer Slaw,
347-971-0906 jenifer.slaw@Goodfuse.com or Trade Media:
Nadine Tosk, 504-453-8344 nadinepr@gmail.com
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