- Two oral presentations highlighting new data
on DaxibotulinumtoxinA for Injection from the SAKURA Phase 3
program, the largest aesthetic neuromodulator clinical program ever
conducted for the treatment of glabellar (frown) lines –
- One oral presentation featuring new interim
analysis data from a Phase 2a open-label study on the safety and
efficacy of DaxibotulinumtoxinA for Injection for the treatment of
lateral canthal lines (crow’s feet) –
- In addition, there will be two ePosters
evaluating the properties of hyaluronic acid-based dermal fillers
–
- Revance to also host ‘Innovative Technology
for the Emerging Demand of Facial Dynamics’ virtual symposium at
ASDS on Saturday, October 10, at 2:30 p.m. ET with Drs. Shannon
Humphrey, Arthur Swift, Benji Dhillon and Charles Boyd -
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology
company focused on innovative aesthetic and therapeutic offerings,
including its investigational neuromodulator product,
DaxibotulinumtoxinA for Injection, today announced three oral
presentations and two ePosters at the American Society for
Dermatologic Surgery (ASDS) Virtual Annual Meeting, October 9-11,
2020. Presented data will showcase novel findings from the SAKURA
Phase 3 program evaluating DaxibotulinumtoxinA for Injection for
the treatment of moderate or severe glabellar (frown) lines, as
well as a 4-week interim analysis from the Phase 2a open-label
study for the treatment of moderate to severe lateral canthal lines
(LCL), commonly known as crow’s feet lines.
“These data underscore the potential of DaxibotulinumtoxinA for
Injection to set a new standard in facial aesthetics treatments and
advance our mission of transforming the patient experience,” said
Roman Rubio, Senior Vice President of Clinical Development at
Revance. “The data from the LCL study were used to optimize our
Phase 2 open-label upper facial lines study, which we expect to
report results from in the fourth quarter of 2020. Additionally,
these findings support our overarching scientific platform as we
continue to establish a new category of long-lasting neuromodulator
products for our prestige aesthetics portfolio.”
The first presentation will report on the efficacy, duration,
and safety of DaxibotulinumtoxinA for Injection in females across
multiple age cohorts following the treatment of glabellar lines in
the SAKURA program. This subgroup analysis demonstrated that the
efficacy and duration of DaxibotulinumtoxinA for Injection for the
treatment of glabellar lines is similarly high in adult females
independent of age. The second presentation will highlight details
from the SAKURA program in which DaxibotulinumtoxinA for Injection
treated subjects showed substantial and progressive improvement in
the severity of glabellar lines at rest following repeated
treatment.
The final presentation will cover 4-week interim data from the
Phase 2a open-label study in crow's feet. Data demonstrated that
following treatment of LCLs with DaxibotulinumtoxinA for Injection,
88% of subjects achieved a score of none or mild at Week 4 in at
least one treatment group. DaxibotulinumtoxinA for Injection
appeared to be well tolerated at all dose levels. These results
were previously announced by Revance in June 2020.
Oral Presentations:
- DaxibotulinumtoxinA for Injection Demonstrates Consistent
Efficacy, Duration, and Safety in Females Independent of Age:
Subgroup Analysis from a Large, Phase 3 Program Friday, October 9,
2020, 9:36 a.m. – 9:39 a.m. ET during the Session #1: Oral
Abstracts. Presenter: Glynis Ablon, M.D., FAAD, Dermatologist at
Ablon Skin Institute and Research Center, Manhattan Beach, CA, and
Associate Clinical Professor at University of California, Los
Angeles, CA, USA
- DaxibotulinumtoxinA for Injection–treated subjects show
progressive improvement in static glabellar lines with repeated
treatment Friday, October 9, 2020, 9:42 a.m. – 9:45 a.m. ET during
the Session #1: Oral Abstracts. Presenter: Richard Glogau, M.D.,
Dermatologist at Glogau Dermatology, San Francisco, CA, and
Clinical Professor of Dermatology University of California, San
Francisco, CA, USA
- DaxibotulinumtoxinA for Injection for Lateral Canthal Lines: A
4-week Interim Analysis Friday, October 9, 2020, 9:39 a.m. – 9:42
a.m. ET during the Session #1: Oral Abstracts. Presenter: Terrence
Keaney, M.D., FAAD, Dermatologist at SkinDC Cosmetic Center,
Arlington, VA, Assistant Clinical Faculty of Dermatology at George
Washington University and Howard University, and Director of the
Laser and Lipoatrophy Clinic at the Veterans Affairs Hospital,
Washington, D.C.
ePosters:
- Rheological Evaluation of the Dynamic Properties of Hyaluronic
Acid-based Dermal Fillers Authors: Vince Bertucci*, Conor
Gallagher†, Jimmy Faivre‡, Kevin Legent‡, Mélanie Gallet‡, Elodie
Tremblais‡, François Bourdon‡ Affiliations: *University of Toronto,
Toronto, Ontario, Canada and private practice, Woodbridge, Ontario,
Canada; †Revance Therapeutics, Inc., Newark, California; ‡Teoxane,
Geneva, Switzerland
- Evaluation of the Impact of Hyaluronic Acid (HA) Filler
Manufacturing Technologies on HA Chain Degradation Authors: Jay
Mashburn†, Jimmy Faivre‡, François Bourdon‡ Affiliations: †Revance
Therapeutics, Inc., Newark, California; ‡Teoxane, Geneva,
Switzerland
Revance is anticipating the U.S. Food and Drug Administration
(FDA) approval of DaxibotulinumtoxinA for Injection in glabellar
(frown) lines in the fourth quarter of this year and is generating
additional data in facial aesthetics, including three Phase 2
open-label trials in lateral canthal (crow’s feet), upper facial
lines and forehead lines. The open-label Phase 2 trial of
DaxibotulinumtoxinA for Injection for the treatment of upper facial
lines – glabellar (frown), lateral canthal (crow’s feet), and
forehead lines combined – completed enrollment in February 2020,
and the company expects to report topline results in the fourth
quarter of 2020.
Complete abstracts, details on presentation times and changes to
presentation dates can be found on the ASDS website. The above
listed dates are subject to change. Please check www.asds.net for
the latest information.
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 in 2020. 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 three therapeutic indications - cervical dystonia, adult
upper limb spasticity and plantar fasciitis. 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 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. RHA resilient hyaluronic
acid® and RHA® are trademarks of TEOXANE SA. BOTOX® is a registered
trademark of Allergan, Inc.
Forward-Looking Statement
This press release contains forward-looking statements,
including statements related to Revance’s financial outlook,
milestone expectations, expected cash runway and financial
performance; the planned commercial launch of our RHA® Collection
of dermal fillers and the HintMD fintech platform, the process and
timing of, and ability to complete, current and anticipated future
clinical development of our investigational drug product
candidates; the initiation, design, enrollment, submission, timing
and results of our clinical studies, including the near-term
milestone expectations described above; development of a biosimilar
to BOTOX®; results of our non-clinical programs; statements about
our business strategy, timeline and other goals and market for our
anticipated products, plans and prospects, including our
commercialization plans; statements about our ability to obtain,
and the timing relating to, regulatory approval with respect to our
drug product candidates, including with respect to the anticipated
approval of DaxibotulinumtoxinA for Injection in glabellar lines
and expected PDUFA date; and potential benefits of our drug product
candidates and our technologies, including with respect to the RHA®
line of dermal fillers and HintMD fintech platform.
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, including our ability to receive timely
approval of DaxibotulinumtoxinA for Injection; 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 and anticipated product
launches; 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 the impact of the
COVID-19 pandemic on our manufacturing operations, supply chain,
business operations, commercialization efforts, end user demand for
our products, clinical trials and other aspects of our business.
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 "Risks
Factors" in the Registration Statement on Form 10Q filed with the
SEC. The forward-looking statements in this press release speak
only as of the date hereof. Revance disclaims any obligation to
update these forward-looking statements.
“Revance Therapeutics” and the Revance logo are registered
trademarks of Revance Therapeutics, Inc.
SOURCES
- Bertucci V, et al. “DaxibotulinumtoxinA for Injection has a
prolonged duration of response in the treatment of glabellar lines:
Pooled data from two multicenter, randomized, double-blind,
placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2).” J Am
Acad Dermatol. 2019;82(4):838-845. doi:
https://doi.org/10.1016/j.jaad.2019.06.1313
- Fabi SG, et al. “DaxibotulinumtoxinA for Injection for the
Treatment of Glabellar Lines: Efficacy Results From SAKURA 3, a
Large, Open-Label, Phase 3 Safety Study.” Dermatologic Surgery.
Published online August 6, 2020. doi:
10.1097/DSS.0000000000002531
- Green JB, et al. “A Large, Open-Label, Phase 3 Safety Study of
DaxibotulinumtoxinA for Injection in Glabellar Lines: A Focus on
Safety From the SAKURA 3 Study.” Dermatologic Surgery. Published
online August 6, 2020. doi: 10.1097/DSS.0000000000002463
- Clinicaltrials.gov. “Efficacy and Safety of Increasing Doses of
DaxibotulinumtoxinA for Injection (DAXI for Injection) in the
Treatment of Moderate or Severe Lateral Canthal Lines.” Available
at:
https://clinicaltrials.gov/ct2/show/NCT03911102?term=DaxibotulinumtoxinA.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201006005464/en/
Media Revance Therapeutics, Inc. Sara Fahy, 949-887-4476
sfahy@revance.com
or
General Media: Y&R: Jenifer Slaw, 347-971-0906
jenifer.slaw@YR.com
or
Trade Media: Nadine Tosk, 504-453-8344
nadinepr@gmail.com
Investors Revance Therapeutics, Inc.: Jeanie Herbert,
714-325-3584 jherbert@revance.com
or
Gilmartin Group, LLC.: Laurence Watts, 619-916-7620
laurence@gilmartinir.com
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