Nashville, Tennessee, October 12, 2021–(BUSINESS WIRE)–Revance Therapeutics, Inc. (NASDAQ: RVNC) is a biotechnology company focused on innovative aesthetics and therapeutic products. It responded to a Freedom of Information Act (FOIA) request against the FDA in response to the public disclosure of Form 483. The Biologics Licensing Application (BLA) for DaxibotulinumtoxinA for injection is still under FDA review, and the company continues to expect the FDA to approve DaxibotulinumtoxinA for injection for the treatment of frown lines in 2021.
Revance pointed out that it is not uncommon for Form 483 to be issued after an on-site inspection. Form 483 lists the observations made by the FDA representative during the inspection of the facility. Form 483 does not constitute a final agency decision.
Revance responded to Form 483 in July 2021 after a pre-approval inspection and is currently awaiting the FDA’s decision on the BLA of DaxibotulinumtoxinA for injection for the treatment of glabellar lines. The company remains confident in the quality of its BLA submissions and continues to expect the FDA to receive approval in 2021.
Revance is a biotechnology company focused on innovative aesthetic and therapeutic products, including its next-generation neuromodulator product DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for injection combines a proprietary stabilized peptide excipient and highly purified botulinum toxin without human or animal components. Revance has successfully completed the third phase of DaxibotulinumtoxinA for intra-brow (frown) injection, and is seeking approval from US regulatory agencies. Revance is also evaluating DaxibotulinumtoxinA for injections across the upper face, including glabellar lines, forehead lines, and crow’s feet, as well as two therapeutic indications-cervical dystonia and adult upper limb spasm. In order to cooperate with DaxibotulinumtoxinA for injection, Revance has a series of unique high-quality products and services used in American beauty practice, including the exclusive distribution rights of RHA® dermal filler series in the United States. This is the first and only one approved by the FDA for use in A series of dynamic fillers to correct facial wrinkles and folds, and OPUL™ relationship business platform. Revance has also partnered with Viatris (formerly Mylan NV) to develop a biosimilar of BOTOX®, which will compete in the existing short-acting neuromodulator market. Revance is committed to changing the status quo by changing the patient experience. For more information or to join our team, please visit www.revance.com.
Any statements in this press release that are not statements of historical facts, including statements related to our ability and time to obtain FDA approval of the BLA for botulinum toxin A for injection for the treatment of frown lines; the quality of our BLA submissions Full of confidence; our BLA submission status; FDA inspection results of the company’s manufacturing facilities in Northern California, and the results of the development of BOTOX® biosimilars with our partner Viatris; constitute the “Private Securities Litigation Reform Act of 1995″, “1933 Forward-looking statements within the meaning of Section 27A of the Securities Act of 1934 (as amended) and Section 21E of the Securities Exchange Act of 1934 (as amended). You should not rely on 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, activity levels, performance, events, circumstances, or achievements reflected in the forward-looking statements will always be realized or occur.
Forward-looking statements are subject to risks and uncertainties, which may cause actual results to differ materially from our expectations. These risks and uncertainties involve, but are not limited to: the results, time, cost, and completion of our R&D activities and regulatory approvals, including the continuing delay in the FDA’s BLA approval of DaxibotulinumtoxinA for injection, for the treatment of glabellar lines, including due to FDA’s observations during on-site inspections or other reasons; the COVID-19 pandemic has imposed on our manufacturing business, supply chain, end-user demand for our products, commercialization efforts, business operations, clinical trials, and other aspects of our business and market We have the ability to manufacture supplies for our product candidates and obtain supplies of the RHA® dermal filler series; uncertain clinical development process; clinical trials may not have effective designs or produce positive results, or positive The results will ensure the risk of regulatory approval or commercial success; the applicability of clinical research results to actual results; the ratio and degree of economic benefits, safety, effectiveness, commercial acceptance, and OPUL™, RHA® dermal filler series and our The market, competition, scale and growth potential of the candidate product (if approved); our ability to continue to successfully commercialize the RHA® dermal filler series and OPUL™, and the ability to successfully commercialize DaxibotulinumtoxinA for injection (if approved), and The time and cost of commercialization activities; our ability to expand sales and marketing capabilities; the status of business cooperation; our ability to obtain funds for our operations; our cost and ability to defend ourselves in product liability, intellectual property and other litigation ; We have the ability to continue to obtain and maintain the intellectual property protection of our drug candidates; our financial performance, including future income, expenses and capital requirements; and other risks. For details on factors that may cause actual results to differ materially from those expressed or implied in the statements in this press release, please refer to our regular documents filed with the United States Securities and Exchange Commission (SEC), including those in the section titled “Risk” The factors described in the “factors” on Form 10-K that we filed with the SEC on February 25, 2021 include but are not limited to the 10th of the quarter ended June 30, 2021, which we filed with the SEC on August 5, 2021. -Q table. The forward-looking statements in this press release are only effective as of the date of publication. We do not undertake any obligation to update these forward-looking statements.
Investor Revance Therapeutics, Inc.: Jessica Serra, 626-589-1007jessica.serra@revance.com or Gilmartin Group, LLC.: Laurence Watts, 619-916-7620laurence@gilmartinir.com
Media Revance Therapeutics, Inc.: Sara Fahy, 949-887-4476sfahy@revance.com or General Media: Y&R: Jenifer Slaw, 347-971-0906jenifer.slaw@YR.com or Trade Media: Nadine Tosk, 504-4453- 834@revance.com gmail.com
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Post time: Oct-13-2021