-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-
NASHVILLE, Tenn.–(BUSINESS WIRE)–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:
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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
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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
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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
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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.
Contacts
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