Revance To Present Clinical Data on DaxibotulinumtoxinA for Injection at the 2022 TOXINS International Conference

Rhea-AI Summary

Revance Therapeutics (RVNC) announced new data on RTP004, enhancing membrane binding of BoNT/A, during a podium presentation at the TOXINS International Conference. The ASPEN-1 Phase 3 trial results for DaxibotulinumtoxinA for cervical dystonia were presented by Dr. Cynthia Comella. The company emphasizes its commitment to neurotoxin research and the therapeutic pipeline's potential. Revance is advancing its long-acting neuromodulator, currently under U.S. regulatory review, while targeting aesthetic and therapeutic markets.

Positive

• New data shows RTP004 enhances membrane binding of BoNT/A.
• The ASPEN-1 Phase 3 trial results support DaxibotulinumtoxinA's efficacy and safety for cervical dystonia.
• Revance is pursuing U.S. regulatory approval for DaxibotulinumtoxinA and expanding its therapeutic pipeline.

Negative

• None.

– New data demonstrating the enhancement of membrane binding of the core neurotoxin of BoNT/A by RTP004, Revance’s novel, excipient peptide –

– A podium presentation on ASPEN-1: A Phase 3 Trial Evaluating the Efficacy, Duration of Effect, and Safety of DaxibotulinumtoxinA for Injection in the Treatment of Cervical Dystonia –

NASHVILLE, Tenn.--(BUSINESS WIRE)-- Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced the presentation of six abstracts to be presented at the 2022 TOXINS International Conference on July 27-30, 2022 in New Orleans, Louisiana.

Among the highlights is a new abstract presenting data demonstrating the enhancement of membrane binding of the core toxin of BoNT/A via Revance’s novel peptide excipient, RTP004. Additionally, data from the ASPEN-1 Phase 3 trial, which evaluated the efficacy, duration of effect, and safety profile of DaxibotulinumtoxinA for Injection in the treatment of cervical dystonia, will be presented by Dr. Cynthia Comella, 2022 President of International Neurotoxin Association (INA). Dr. Comella is a leader in clinical neurotoxin research, and is the author of more than 180 articles, reviews, research papers, abstracts, and books.

“Our latest scientific findings and introduction of new data underscores Revance’s commitment to the advancement of research of neurotoxins in both aesthetic and therapeutic indications, while reinforcing DaxibotulinumtoxinA for Injection’s differentiated performance profile,” said Conor Gallagher, Vice President of Medical Affairs and Scientific Innovation at Revance. “The presentation of this data demonstrates Revance’s drive for innovation in facial aesthetics and supports the strong potential of our therapeutic pipeline in the neurotoxin category. We are pleased to continue to realize the potential of our investigational neurotoxin and share these discoveries with the greater scientific community.”

Posters:

• Title: ASPEN-1: A Phase 3 Trial Evaluating the Efficacy, Duration of Effect, and Safety of DaxibotulinumtoxinA for Injection in the Treatment of Cervical Dystonia
• Authors and Affiliations: Joseph Jankovic, Cynthia Comella, Robert A. Hauser, Atul T. Patel, Todd M. Gross, Roman G. Rubio, Domenico Vitarella, Parkinson’s Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine, Houston, TX; Rush University Medical Center, Chicago, IL; University of South Florida, Tampa, FL; Kansas City Bone & Joint Clinic, Overland Park, KS; Revance Therapeutics, Inc., Nashville, TN
  

• Title: A Cell-Penetrating Peptide Binds Directly to and Enhances Membrane Binding of the Core Toxin of Botulinum Neurotoxin Serotype A
• Authors and Affiliations: Michael J. Pulkoski-Gross, Julie Chu, Rainy Shai, Priscilla Too, Revance Therapeutics, Inc., Nashville, TN
  

• Title: DaxibotulinumtoxinA for Injection Demonstrates Consistent Safety and Efficacy in Black Subjects: Subgroup Analysis From a Large, Open Label Repeat-Dose Study
• Authors and Affiliations: Charles Boyd, Valerie Callender, Cheryl Burgess, Jessica Brown, Conor J. Gallagher, Boyd Beauty, Birmingham MI, Callendar Center for Clinical Research, Glenn Dale, MD, Center for Dermatology and Dermatologic Surgery, Washington, DC, Revance Therapeutics Inc., Nashville, TN
  

• 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, Jeffrey S. Dover, Ronald R. Bowsher, Amanda Clancy, Liu, Conor Gallagher, University of British Columbia and Humphrey Cosmetic Dermatology, Vancouver, British Columbia, Canada; Skin Care Physicians, Chestnut Hill, MA; B2S Life Sciences, Franklin, IN; Revance Therapeutics Inc., Nashville, TN
  

• Title: Biochemical Stability and Microbial Control of Reconstituted DaxibotulinumtoxinA for Injection (DAXI)
• Authors and Affiliations: Mung Bernarndo, Kimberlee Ellis, Thai Thach; Revance Therapeutics Inc., Nashville, TN
  

• Title: A Phase 3, Open-Label, Multicenter Trial to Evaluate the Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia
• Authors and Affiliations: Jaroslaw Slawek, Peter McAllister, Sebastian Paus, Daniel Truong, Todd M. Gross, Roman G. Rubio, Pat Kesslak, Domenico Vitarella, Al. Jana Pawla, Medical University of Gdańsk, Gdańsk, Poland; St. Adalbert Hospital, Gdańsk, Poland; New England Institute for Neurology and Headache, Stamford, CT, Department of Neurology, University of Bonn, Bonn, Germany; Department of Neurology, GFO Kliniken Troisdorf, Troisdorf, Germany; University of California, Riverside, CA; The Parkinson and Movement Disorder Institute, Fountain Valley, CA; Revance Therapeutics, Inc., Nashville, TN

The above presentations will be live for the duration of the TOXINS Conference and available for conference attendees online for six months post-meeting. Complete abstracts, details on presentation times and dates can be found on the TOXINS 2022 website. Please visit www.neurotoxins.org/toxins-2022 for the latest information.

About Revance

Revance is a commercial stage biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation, long-acting neuromodulator product, DaxibotulinumtoxinA for Injection. Revance has successfully completed Phase 3 clinical programs for DaxibotulinumtoxinA for Injection in glabellar (frown) lines, for which the company is currently pursuing U.S. regulatory approval, and in cervical dystonia. Revance is also evaluating DaxibotulinumtoxinA for Injection in adult upper limb spasticity. 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 in adults ages 22 years or older, and the OPUL™ Relational Commerce Platform. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which if approved, would be the first and only generic biosimilar to Botox® and Botox® Cosmetic. 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 Statement

Any statements in this press release that are not statements of historical fact, including statements related to the performance profile of DaxibotulinumtoxinA for Injection; the safety, efficacy and duration of DaxibotulinumtoxinA for Injection; the potential of our therapeutics pipeline; development of a biosimilar to BOTOX® with our partner, Viatris; and 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, our ability to remediate deficiencies identified by the FDA and obtain FDA approval of the BLA for DaxibotulinumtoxinA for Injection for glabellar lines, including as a result of observations made by the FDA during the site inspection or other reasons; our ability to obtain funding for our operations; the timing of capital expenditures; 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 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, inspections 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; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; 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-Q filed with the SEC on May 10, 2022. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220727005187/en/

Media

Revance Therapeutics, Inc.:

Sara J. Fahy

Media@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

Source: Revance Therapeutics, Inc.

FAQ

What new data did Revance Therapeutics present at the TOXINS International Conference?

Revance presented data showing that RTP004 enhances membrane binding of BoNT/A.

What is the ASPEN-1 trial related to Revance?

The ASPEN-1 trial evaluates the efficacy, duration of effect, and safety of DaxibotulinumtoxinA for cervical dystonia.

Is DaxibotulinumtoxinA for Injection under regulatory review?

Yes, Revance is currently pursuing U.S. regulatory approval for DaxibotulinumtoxinA.

What are Revance's future plans for their neurotoxin product pipeline?

Revance aims to advance its therapeutic pipeline, focusing on innovative neurotoxin offerings in both aesthetic and therapeutic markets.