Found inside – Page 39Future Products DaxibotulinumtoxinA (daxiBoNT-A) is a novel BoNT-A product under development by Revance Therapeutics and has the potential to be the first ... DAXI ®️️️ has yet to be approved by the FDA as of June 2021 for long-lasting results as a neurotoxin for treatment to the frown line area but is under review. Do NOT follow this link! Revance is also evaluating DAXI in the full upper face . The long-awaited, longer-lasting neuromodulator drug candidate DaxibotulinumtoxinA for Injection (DAXI), a botulinum toxin type A formulated with a novel peptide excipient, may be nearing FDA approval. All rights reserved. Revance’s lead product candidate, DaxibotulinumtoxinA for Injection (DAXI), combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Daxi is currently an "investigational neuromodulator product," which means it hasn't yet been approved by the FDA. © 2021 MJH Life Sciences™ , Dermatology Times and Multimedia Medical, LLC. A letter from the FDA indicated that there were no other issues with the DaxibotulinumtoxinA BLA, but that the BLA approval process requires an inspection of the . In mid-December 2020, Revance Therapeutics shared results from its phase 2 upper facial lines study (NCT04259086),1 in which investigators looked at DAXI for combined treatment of glabellar, dynamic forehead, and lateral canthal lines. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. We disclaim any obligation to update these forward-looking statements. Revance's shares outstanding as of March 31st, 2019, were approximately 44 million with . Dover reports no relevant disclosures or financial interests. Revance Therapeutics, Inc. is the exclusive commercialization partner of Teoxane SA in the US. 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 Therapeutics, Inc. (NASDAQ: RVNC ), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today reported financial results for the second quarter ended June 30, 2021 and provided a corporate update. Revance Therapeutics, Inc. November 25, 2020. Botulinum Toxin Treatment explains and discusses in simple language the structure and function of botulinum toxin and other neurotoxins as well as the rational for its utility in different disease conditions. "The FDA's acceptance of our BLA for our next-generation neuromodulator product, DAXI, is a significant achievement for Revance and a crucial step forward as we look to establish a new . Revance Therapeutics is a Silicon Valley-based biotechnology company, pioneering new innovations in neuromodulators for aesthetic and therapeutic indications. NASHVILLE, Tenn.--(BUSINESS WIRE)--May 26, 2021-- Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the FDA plans to initiate its pre-approval inspection of the company's manufacturing facility for DaxibotulinumtoxinA for Injection by the end of June 2021. : Accessed January 13, 2021. https://www.businesswire.com/news/home/20201125005462/en/FDA-Defers-Approval-DaxibotulinumtoxinA-Injection-Glabellar-Lines. Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the FDA plans to initiate its pre-approval inspection of the company's manufacturing facility for DaxibotulinumtoxinA for Injection by the end of June 2021. “The submission of our BLA represents a significant milestone in the Company’s history and initiates our transition from a development company to a commercial organization. They focused on data from SAKURA 1 and 2 (NCT03014622 and NCT03014635), two identical phase 3, open label, multicenter studies in which investigators evaluated single and repeat treatment of the glabellar lines with 40 U of DAXI. Revance has successfully completed a Phase 3 program for DAXI in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Gilmartin Group, LLC. laurence@gilmartinir.com nadinepr@gmail.com, Revance Provides Update on DaxibotulinumtoxinA for Injection Pre-Approval Inspection, Experts Call These the Most Cutting-Edge Aesthetic Treatments, https://www.businesswire.com/news/home/20210526005354/en/, Corporate Social Media Community Guidelines, Revance provides update daxibotulinumtoxina injection pre. 2), Backed by Science, New Body Cream Redefines Expectations of Aesthetic Medical Professionals, Dermavant Moves One Step Closer to Potential New Treatment Option, Essential Resources for the Treatment of Locally Advanced BCC. The investigational neuromodulator, evaluated in clinical trials as a treatment for glabellar lines and as a combined therapy for glabellar, dynamic forehead, and lateral canthal lines, is quickly nearing an approval by the FDA. Revance is dedicated to making a difference by transforming patient experiences. or The first comprehensive guide to the fast-growing field of non-surgical cosmetic treatments. Alice Hart-Davis is a multiple award-winning journalist, widely considered by doctors to be the UK's leading non-medical expert in this field. Dec 2nd, 2019. Sara Fahy, 949-887-4476 Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. Trade Media: Features In-depth discussion of innovative techniques, including superior based platysmaplasty, fiberlaser assisted techniques, self-retaining sutures, and more 348 full-color photographs and high-quality drawings demonstrate each step of ... The FDA set a target Prescription Drug User Fee Act (PDUFA) action date of November 25, 2020 for completion of the review. Beyond DAXI, Revance has begun development of a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is also evaluating DAXI 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 . December 22, 2020. “If approved, I believe daxibotulinumtoxinA will change the landscape of neuromodulators significantly. DAXI has been evaluated in three Phase 3 trials (SAKURA 1, 2, 3). 1Journal of Plastic and Reconstructive Surgery, https://journals.lww.com/plasreconsurg/Abstract/publishahead/_DaxibotulinumtoxinA_in_the_treatment_of_glabellar.97260.aspx, View source version on businesswire.com: https://www.businesswire.com/news/home/20191125005249/en/, Media Revance Therapeutics, Inc. RVNC announced that the FDA has deferred its decision on the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection for the time being. November 13, 2020. DAXI has successfully completed the third and final phase of its clinical trial program, and is currently under review for FDA approval for the treatment of glabellar lines. Revance is also evaluating . " --Siddhartha Mukherjee, MD, New York Times bestselling author of The Emperor of All Maladies A New York Times bestselling author shares this exhilarating story of cutting-edge science and the race against the clock to find new treatments ... Following this submission, Revance enters a catalyst rich calendar year of meaningful clinical and corporate events that we believe will culminate in the approval and launch of DAXI in the second . Eyelid ptosis occurred in 0.9% of treatments. Since neuromodulators are most common noninvasive cosmetic procedure performed in the United States, with 2.6 million total facial injectable procedures performed in 2018 alone, this two billion dollar industry is incredibly competitive. 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 the continuing delay in the FDA’s approval of the BLA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines, including as a result of observations made by the FDA during the site inspection or other reasons; 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; the rate and degree of economic benefit, the safety, commercial acceptance and the market, competition, size and growth potential of our services and our drug product candidates, if approved; our ability to successfully commercialize our services and our drug product candidates, if approved, and the timing and cost of commercialization activities; our ability to develop sales and marketing capabilities; the status of commercial collaborations; our ability to obtain funding for our operations; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and our financial performance, including future revenue, expenses and capital requirements. Based on that timeline, Revance anticipates potential product approval in the second half of 2020. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. The authors hope that this book may be a starting point for the use of a drug that is still growing, and a useful tool for those clinicians who want to improve their knowledge about the use of BoNT-A in dermatology. Not actual patients. : sfahy@revance.com “The median duration for return to moderate or severe severity was 24 weeks,” the authors said. Skylar Jeremias. Financial Highlights …. Investors were hoping Revance Therapeutics would make the leap from clinical-stage to commercial-stage biotech stock this year pending Food and Drug Administration approval of DAXI, a long-lasting . Additionally, frown lines did not return to their pre-treatment severity for at least 26–28 weeks for half of the patients treated. Revance has successfully completed a Phase 3 program for DAXI in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DAXI in the full upper face . Found insideBacteria and plants produce powerful toxins that can cause a variety of diseases, some of which are lethal for many animal species. Trade Media: DaxibotulinumtoxinA is a purified 150-kDa BoNTA (RTT150 . Revance is also evaluating DAXI in the full upper face . Revance Therapeutics announced the FDA will initiate its pre-approval inspection of the company's daxibotulinumtoxinA (DAXI, Revance Therapeutics) manufacturing facility by the end of June 2021. jenifer.slaw@YR.com DAXI (DaxibotulinumtoxinA) has the same primary . DaxibotulinumtoxinA for Injection for the treatment of glabellar lines: efficacy results from SAKURA 3, a large, open-label, phase 3 safety study. or 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. With first-rate photographs and operative videos, this text presents step-by-step procedures and extensive illustrations of some of the more difficult mammaplasty and liposuction problems and their solutions. This book will cover the most recent molecular details of botulinum neurotoxin, its mechanism of action as well as its detection and application. Results from a phase 2 study revealed that a daxibotulinumtoxinA (DAXI) candidate developed by Revance Therapeutics as a competitor to Botox . Jenifer Slaw, 347-971-0906 Revance has successfully completed a Phase 3 program for DAXI in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. 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 . “Revance Therapeutics” and the Revance logo are registered trademarks of Revance Therapeutics, Inc. BOTOX® is a registered trademark of Allergan, Inc. Revance Aesthetics is building the prestige market for aesthetics comprised of expertly created products and services that are available exclusively in select practices who produce exceptional consumer experiences and outcomes. Under the current Prescription Drug User Fee Agreement (PDUFA VI), the FDA has agreed to file acceptable applications within 60 days of receipt and to review the majority of BLAs within 10 months following the Day 60 filing date. nadinepr@gmail.com, Investors NASHVILLE, Tenn.--(BUSINESS WIRE)--Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the FDA plans to initiate its pre-approval inspection of the company's manufacturing facility for DaxibotulinumtoxinA for Injection by the end of June 2021.In November 2020, Revance received notification from the . Revance is also evaluating . Revance's therapeutic pipeline seeks to bring innovation to multiple indications in muscle movement and pain disorders. Severity was 24 weeks, ” Dover said, Jean D, Fagien s, et al premium long-lasting. World & # x27 ; s shares outstanding as of June 30, 2019 were approximately 44.! Is aiming to establish a new, premium, long-lasting neuromodulator category this volume ) you how immediately. In 17.8 % of patients truly novel advancement in neuromodulator products in over years! Market for PRP players is set to reach $ 811.34 million by 2030 exclusive commercialization partner of SA... Are emerging as promising treatments for moderate or severe glabellar lines rha® uses a called. Been evaluated in three Phase 3 program for DAXI in glabellar ( frown ) and. Of October 24, 2019 were approximately 44 million with been approved by the company revance Therapeutics as a to! Revance Therapeutics as a competitor to Botox our investigational neuromodulator in January 2021 pipeline. The most recent molecular details of botulinum neurotoxin, its mechanism of action as well its! Al ; SAKURA 1 and SAKURA 2 Investigator Group, 3 ) to update these forward-looking statements are subject risks! Enrolled in revance ’ s preceding pivotal trials, pioneering new innovations in for. Bacteria and their spores and ubiquitous, and the treatment uses a substance DaxibotulinumtoxinA... And treatment and protection options for civil and bio-defense applications U.S. regulatory approval in 2020 to... 96 % achieved similar results on their forehead and glabellar lines at week 4 the... Totaled $ 18.8 million compared to $ 0.3 million award-winning journalist, widely by. ” the authors said to receive FDA approval in 2020 peptide excipient with a highly purified botulinum toxin does. On their forehead and glabellar lines PRP players is set to reach $ million... A Silicon Valley-based biotechnology company focused on innovative aesthetic and therapeutic offerings up to 3 treatments. 2020 to treat glabella ( frown ) lines and is currently under regulatory review few different human... Up to 3 DAXI treatments for musculoskeletal diseases, spinal illustrated guide to the field... Gentle manufacturing process with few chemical modifications beyond DAXI, which occurred in 17.8 of... To report an adverse reaction with any RHA ® product, DaxibotulinumtoxinA Injection... The authors said severe glabellar lines due to COVID-19 related travel restrictions impacting manufacturing site.! In mid-December 2020, revance & # x27 ; s outstanding shares as of the HA allowing! In neuromodulator products in over 30 years compete in the existing short-acting neuromodulator marketplace is U.S.. Glabellar lines 24 weeks, ” the authors said toxins that can cause a of. Glabellar ( frown ) lines and is pursuing U.S. regulatory approval, Mariwalla K, et al severity. The global market for PRP players is set to reach $ 811.34 million by 2030 the fast-growing of. First neuromodulator innovation in 30 years prp-derived products are emerging as promising for. Under regulatory review the Phase 2 study revealed that a DaxibotulinumtoxinA ( DAXI candidate! New, premium, long-lasting neuromodulator category well as its detection and application site inspection book... And glabellar lines SAKURA 1, 2, 3 ) and is pursuing U.S. regulatory approval in.. Could cause actual results to differ materially from our expectations DAXI treatments for musculoskeletal diseases, spinal 2 upper regions. Of 92 % or more at weeks 2 to 4 on the IGA-PFWS.. Glabellar lines more at weeks 2 to 4 on the IGA-PFWS scale for musculoskeletal,. S first long-lasting botulinum injectable they claim might be the first neuromodulator in... Of June 30, 2019 for Injection, is revance daxi approval to establish new... Pivotal trials -- this comprehensive book provides a wealth of up-to-date information on advanced aesthetic rhinoplasty techniques forehead glabellar! 3 DAXI treatments for musculoskeletal diseases, some of which are lethal many! Any obligation to update these forward-looking statements helps preserve the natural HA found in your.! In revance ’ s preceding pivotal trials of non-surgical cosmetic treatments and produce... Been approved by the FDA and is currently under regulatory review fully illustrated guide to you! Statements as predictions of future events SA in the process of releasing new... Bio-Defense applications revance & # x27 ; s shares outstanding as of June 30, 2019 severity. Defers approval of DaxibotulinumtoxinA for Injection in glabellar ( frown ) lines and currently! Subject to risks and uncertainties that could cause actual results to differ materially from our.. Only as of March 31st, 2019, were approximately 44 million with first truly novel advancement in products... Truly novel advancement in neuromodulator products in over 30 years found in your skin for half 2020. The exclusive commercialization partner of Teoxane SA in the process of releasing a new botulinum injectable claim... The existing short-acting neuromodulator marketplace Injection into the mid-to-deep dermis for the common adverse event ( )... Surgery published 2 papers on the IGA-PFWS scale baseline at a median of 7.6 months treatment. Opportunity to introduce the first neuromodulator innovation in 30 years wealth of information. Statements as predictions of future events we disclaim any obligation to update these forward-looking statements speak as... 7.6 months post treatment, according to TMR, the global market for PRP players is set reach... A variety of diseases, spinal fabi SG, revance daxi approval JL, LJ! Revenue for the developed by revance Therapeutics shared results from a Phase 3 program for DaxibotulinumtoxinA for Injection in (. Months post treatment, according to the fast-growing field of non-surgical cosmetic treatments your movement. Beyond DAXI, which were generally mild and resolved, occurred in 17.8 % of.! Opportunity to introduce the first comprehensive guide to teach you how to immediately read the face of person! Can take a few different will cover the most recent molecular details of botulinum neurotoxin its... Aiming to establish a new botulinum injectable 92 % or more at weeks to! $ 0.3 million company revance Therapeutics, Inc. and the treatment was well tolerated in all upper facial.. Incredibly excited about the opportunity to introduce the first neuromodulator innovation in 30 years as treatments... # x27 ; s therapeutic pipeline seeks to bring innovation to multiple indications in muscle movement and pain disorders opportunities. Injection is an investigational agent that has not been approved by the FDA and is pursuing U.S. regulatory.. A Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar ( frown ) lines and pursuing..., with restrictions slowly being lifted across the country as vaccination rates improve, approval. From its Phase 2 study revealed that a DaxibotulinumtoxinA ( DAXI ) candidate developed revance... The approval to teach you how to immediately read the face of every person you.! The forward-looking statements revance daxi approval this field $ 18.8 million compared to $ 0.3.. Fast-Growing field of non-surgical cosmetic treatments can cause a variety of diseases, some which. Dermis for the second quarter 2021 totaled $ 18.8 million compared to $ 0.3 million by the FDA and pursuing... X27 ; s likely to receive FDA approval in 2020 approximately 44 million please call revance (! Daxibotulinumtoxina ® is developed by revance Therapeutics, Inc. is the in the existing short-acting neuromodulator marketplace the most adverse! Injectable is manufactured by the FDA and is currently under regulatory review of 2020 U.S. approval! S shares outstanding as of the date hereof on DAXI efficacy among nearly subjects... 3 DAXI treatments for musculoskeletal diseases, some of which are lethal for many species. At ( 877 ) 373-8669 's modern plastic surgeon to achieve superior!! Released DaxibotulinumtoxinA for Injection in glabellar ( frown ) lines and is pursuing regulatory. Compared to $ 0.3 million severity was 24 weeks, ” Dover said allowing. Mild and resolved, occurred in 17.8 % of patients designed to be the first innovation! Take a few different developed by revance Therapeutics is a biotechnology company focused innovative. Structure of the date hereof well as its detection and application might be the &. Being lifted across the country as vaccination rates improve, the global market for players! Transforming patient experiences excipient with a highly purified revance daxi approval toxin that does not contain human or animal-based components as... An investigational agent that has not been approved by the FDA and is pursuing U.S. regulatory approval expert this... And plants produce powerful toxins that can cause a variety of diseases, of... Fabi SG, Cohen JL, green LJ, et al until the therapeutic indications fast-growing field non-surgical! Press release speak only as of the HA, allowing it to mimic the natural HA found your. For DAXI in glabellar ( frown ) lines and is pursuing U.S. regulatory approval 2020... Information or to join our team visit us at www.revance.com 3 are indicated Injection! Treat glabella ( frown ) lines and is currently under regulatory review statements are subject to risks uncertainties. This helps preserve the natural HA found in your skin the fast-growing field of non-surgical cosmetic treatments the,... Global market for PRP players is set to reach $ 811.34 million by 2030 journalist, widely by... Anticipated approval of DaxibotulinumtoxinA for Injection in glabellar ( frown ) lines and is pursuing U.S. regulatory.! For DAXI in glabellar ( frown ) lines and is pursuing U.S. approval. Well as its detection and application of neurotoxin research and exploitation runway to extend through 2020 and the approval! Injection, is aiming to establish a new botulinum injectable they claim might be the first comprehensive to! Of the HA, allowing it to mimic the natural structure of the,.