Revance to Present Data on DaxibotulinumtoxinA for Injection & Hyaluronic Acid Fillers at American Academy of Dermatology VMX...
April 23 2021 - 8:00AM
Business Wire
-New DaxibotulinumtoxinA for Injection results
from the SAKURA Phase 3 program will be presented, as well as two
additional ePoster presentations-
-Additional ePoster presentation highlighting
findings from a study evaluating hyaluronic acid (HA) filler
manufacturing technologies on HA chain degradation will be
shared-
Revance Therapeutics, a biotechnology company focused on
innovative aesthetic and therapeutic offerings, today announced
that it will present four ePoster abstracts at the virtual American
Academy of Dermatology (AAD VMX) meeting, April 23-25, 2021,
including new data from the SAKURA Phase 3 clinical program for
DaxibotulinumtoxinA for Injection, the company’s investigational,
next-generation neuromodulator. The company will showcase new
results on the elimination of glabellar lines following treatment
with DaxibotulinumtoxinA for Injection, made evident through a
novel approach visualizing the entire distribution of glabellar
line severity ratings in the depiction of efficacy.
A second ePoster will highlight data from a subgroup analysis on
the efficacy, duration and safety of DaxibotulinumtoxinA for
Injection among adult female subjects across multiple age cohorts
from the SAKURA Phase 3 program, and a third ePoster will include
results from an evaluation of the progressive effects on
static/resting glabellar lines with the repeated treatment of
DaxibotulinumtoxinA for Injection. A fourth ePoster will highlight
results from a study evaluating the impact of hyaluronic acid (HA)
filler manufacturing technologies on HA chain degradation.
“We look forward to sharing new data from our SAKURA Phase 3
program with the aesthetic community at AAD VMX, as well as
highlighting study results of our hyaluronic acid fillers
manufacturing technology,” said Roman Rubio, Senior Vice President
of Clinical Development at Revance. “These data continue to
underscore the innovation that drives Revance’s aesthetics
portfolio, including our investigational neuromodulator product,
DaxibotulinumtoxinA for Injection, and the RHA® Collection, which
was launched in September 2020.”
The abstracts are available online via the AAD VMX website at
www.aad.org. Attendees can access all of the sessions on-demand
through July 12, 2021.
Abstracts to be presented at AAD:
- Title: Visualizing the Elimination of Glabellar Lines
Following Treatment with DaxibotulinumtoxinA for Injection (DAXI)
Authors and Affiliations: Shannon Humphrey, Humphrey
Cosmetic Dermatology, Vancouver, British Columbia, Canada, Sabrina
Fabi, Cosmetic Laser Dermatology, San Diego, CA, USA, Derek Jones,
Skin Care and Laser Physicians of Beverly Hills, Beverly Hills, CA,
USA, Todd Gross, Yan Liu, Roman Rubio, Revance Therapeutics, Inc.,
Newark, CA, USA
- Title: DaxibotulinumtoxinA for Injection (DAXI)–treated
Subjects Show Progressive Improvement in Static Glabellar Lines
With Repeated Treatment Authors and Affiliations: Richard
Glogau, Department of Dermatology, University of California at San
Francisco, San Francisco, CA, USA, Theda Kontis, Johns Hopkins
Medical Institutions, Baltimore, MD, USA, Yan Liu, Conor J
Gallagher, Revance Therapeutics, Inc., Newark, CA, USA
- Title: DaxibotulinumtoxinA for Injection (DAXI)
Demonstrates Consistent Efficacy, Duration, and Safety in Females
Independent of Age: Subgroup Analysis from a Large, Phase 3 Program
Authors and Affiliations: Glynis Ablon, Ablon Skin
Institute, Manhattan Beach, CA, Ava Shamban, Ava MD, Santa Monica
& Beverly Hills, CA, Susan Weinkle, Susan H. Weinkle, MD,
Bradenton, FL, Jessica Brown, Yan Liu, Revance Therapeutics, Inc.,
Newark, CA
- Title: Evaluation of the Impact of Hyaluronic Acid (HA)
Filler Manufacturing Technologies on HA Chain Degradation
Authors and Affiliations: Jay Mashburn, Revance
Therapeutics, Inc., Newark, CA, Jimmy Faivre, François Bourdon,
Teoxane, Geneva, Switzerland
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 the results of the
SAKURA Phase 3 clinical program, development of a biosimilar to
BOTOX® and potential benefits of our drug product candidates and HA
filler manufacturing 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/20210423005004/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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