Revance to Present New Clinical Data on DaxibotulinumtoxinA for Injection from the ASPEN Phase 3 Program at the 2022 American Academy of Neurology Annual Meeting

Rhea-AI Summary

Revance Therapeutics announced presentations at the 2022 American Academy of Neurology Annual Meeting, showcasing data on DaxibotulinumtoxinA for Injection. The oral presentation will cover the ASPEN-1 Phase 3 trial results, demonstrating significant efficacy and safety in treating cervical dystonia. The study revealed two effective doses compared to placebo, with positive long-term safety results from the ASPEN Open Label Study (OLS). This positions DaxibotulinumtoxinA as a promising treatment, bolstering Revance's innovative product line.

Positive

• Successful ASPEN-1 Phase 3 trial results indicate long-term safety and efficacy of DaxibotulinumtoxinA for Injection.
• DaxibotulinumtoxinA showed positive efficacy with two effective doses compared to placebo.
• Long-term safety data reinforces the positive outcomes of the pivotal study.

Negative

• None.

- Two presentations highlighting data on DaxibotulinumtoxinA for Injection, including Revance’s first oral presentation of the ASPEN-1 Phase 3 clinical trial data, and one poster detailing the positive topline results from the ASPEN Open Label Study (OLS), which demonstrated long-term safety and efficacy of repeat treatments –

NASHVILLE, Tenn.--(BUSINESS WIRE)-- Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced they will give one oral presentation and present one poster at the 2022 American Academy of Neurology Annual Meeting, taking place on April 2-7, 2022 in Seattle, Washington.

“We look forward to participating at AAN this year, where we will give our first, in-person oral presentation of the ASPEN-1 Phase 3 clinical trial results, and also present new data from the ASPEN-OLS Phase 3 open-label, long-term safety study of DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia,” said Mark J. Foley, Chief Executive Officer of Revance. “As we seek to help patients with this debilitating condition achieve long-lasting symptom relief, the important data from our ASPEN-1 Phase 3 program continues to show DaxibotulinumtoxinA for Injection’s long duration of effect and encouraging safety profile. The pivotal ASPEN-1 trial demonstrated two efficacious and well-tolerated dose levels of DaxibotulinumtoxinA for Injection compared to placebo, with consistent patient and clinician reports of improvement and treatment satisfaction. Results from the ASPEN-OLS study reinforce the long-term safety and efficacy of our pivotal study with up to four repeat doses.”

Oral Presentation:

• Title: A Phase 3 Trial Evaluating the Efficacy, Duration of Effect, and Safety of DaxibotulinumtoxinA for Injection in the Treatment of Cervical Dystonia
• Presented by: Dr. Robert A. Hauser
• 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, Rush University Medical Center, University of South Florida, Kansas City Bone & Joint Clinic, Revance Therapeutics, Inc., Nashville, TN

Poster:

• Title: A Phase 3, Open-Label, Multi-Center 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, Medical University of Gdańsk and St. Adalbert Hospital, New England Institute for Neurology and Headache, University of Bonn, University of California and The Parkinson and Movement Disorder Institute, Revance Therapeutics, Inc., Nashville, TN

The above abstracts are available online via the AAN website at www.aan.com.

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, 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 Statements

Any statements in this press release that are not statements of historical fact, including statements related to the potential benefits, efficacy and duration of DaxibotulinumtoxinA for Injection and our development of a biosimilar to BOTOX® with our partner, Viatris, 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" in our Form 10-K, filed with the SEC on February 28, 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/20220328005126/en/

Media

Revance Therapeutics, Inc.:

Sara Fahy, 949-887-4476

sfahy@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 were the results of the ASPEN-1 Phase 3 trial for RVNC?

The ASPEN-1 Phase 3 trial demonstrated significant efficacy and safety of DaxibotulinumtoxinA for Injection in treating cervical dystonia, with two effective doses compared to placebo.

When will Revance present its Phase 3 trial data?

Revance will present its Phase 3 trial data at the 2022 American Academy of Neurology Annual Meeting from April 2-7, 2022.

What is the significance of the ASPEN Open Label Study for RVNC?

The ASPEN Open Label Study provided positive long-term safety and efficacy results for DaxibotulinumtoxinA, reinforcing findings from the ASPEN-1 trial.

How does DaxibotulinumtoxinA for Injection impact cervical dystonia treatment?

DaxibotulinumtoxinA for Injection offers a long duration of effect and a favorable safety profile, making it a promising option for cervical dystonia management.

What should investors know about RVNC's upcoming presentations?

Investors should note that Revance's upcoming presentations may highlight the effectiveness and potential market impact of DaxibotulinumtoxinA, which could influence RVNC's stock performance.