Nashville, Tennessee, Okutobala 12, 2021–(BUSINESS WIRE)–Revance Therapeutics, Inc. (NASDAQ: RVNC) ndi kampani yasayansi yazachilengedwe yomwe imayang'ana kwambiri kukongola kwatsopano ndi mankhwala achire.Inayankha pempho la Freedom of Information Act (FOIA) lotsutsana ndi FDA poyankha kuwululidwa kwa anthu kwa Fomu 483. The Biologics Licensing Application (BLA) ya DaxibotulinumtoxinA ya jekeseni idakali pansi pa FDA, ndipo kampani ikupitiriza kuyembekezera FDA. kuvomereza DaxibotulinumtoxinA jakisoni wochizira tsinya mu 2021.
Revance adanenanso kuti si zachilendo kuti Fomu 483 iperekedwe pambuyo poyang'anira malo.Fomu 483 imatchula zomwe woimira FDA adawona poyendera malowa.Fomu 483 sipanga chigamulo chomaliza cha bungwe.
Revance adayankha Fomu 483 mu Julayi 2021 atayang'anira chivomerezo chisanachitike ndipo pano akuyembekezera chigamulo cha FDA pa BLA ya DaxibotulinumtoxinA pochiza mizere ya glabellar.Kampaniyo idali ndi chidaliro pa zomwe BLA idapereka ndipo ikupitilizabe kuyembekezera kuti FDA ilandila chivomerezo mu 2021.
Revance ndi kampani yasayansi yazachilengedwe yomwe imayang'ana kwambiri zinthu zatsopano zokometsera komanso zochizira, kuphatikiza mankhwala ake amtundu wotsatira wa neuromodulator DaxibotulinumtoxinA for Injection.DaxibotulinumtoxinA ya jekeseni imaphatikiza peptide yokhazikika yokhazikika komanso poizoni wa botulinum woyeretsedwa kwambiri wopanda anthu kapena nyama.Revance yamaliza bwino gawo lachitatu la DaxibotulinumtoxinA ya jakisoni wapakati pa nkhonya, ndipo akufuna kuvomerezedwa ndi mabungwe olamulira aku US.Revance ikuwunikanso DaxibotulinumtoxinA ya jakisoni pamwamba pa nkhope, kuphatikizapo mizere ya glabellar, mizere ya pamphumi, ndi mapazi a khwangwala, komanso zizindikiro ziwiri zochiritsira - khomo lachiberekero dystonia ndi kumtunda kwa miyendo ya wamkulu.Pofuna kugwirizana ndi DaxibotulinumtoxinA pa jakisoni, Revance ili ndi mndandanda wazinthu zapadera zamtengo wapatali ndi mautumiki omwe amagwiritsidwa ntchito muzochita za kukongola kwa America, kuphatikizapo ufulu wogawira wa RHA® dermal filler series ku United States.Ili ndi loyamba komanso lokhalo lovomerezedwa ndi FDA kuti ligwiritsidwe ntchito mu A mndandanda wazodzaza zosinthika kuti ziwongolere makwinya amaso ndi mapindikidwe, ndi nsanja ya bizinesi ya OPUL™.Revance adagwirizananso ndi Viatris (omwe kale anali Mylan NV) kuti apange biosimilar ya BOTOX®, yomwe idzapikisane ndi msika wa neuromodulator womwe ulipo wanthawi yayitali.Revance akudzipereka kuti asinthe momwe zinthu zilili posintha zochitika za odwala.Kuti mumve zambiri kapena kulowa nawo gulu lathu, chonde pitani www.revance.com.
Mawu aliwonse omwe ali m'nkhani ino atolankhani omwe sali mbiri yakale, kuphatikiza mawu okhudzana ndi kuthekera kwathu ndi nthawi yoti tipeze chivomerezo cha FDA cha BLA cha poizoni wa botulinum A pochiza mizere yokwinya;mtundu wa zomwe tapereka ku BLA Wodzaza ndi chidaliro;kugonjera kwathu kwa BLA;FDA kuyendera zotsatira za malo opanga makampani ku Northern California, ndi zotsatira za chitukuko cha BOTOX® biosimilars ndi bwenzi lathu Viatris;amapanga "Private Securities Litigation Reform Act of 1995", "1933 Zoyang'ana Patsogolo mkati mwa tanthauzo la Gawo 27A la Securities Act la 1934 (monga lasinthidwa) ndi Gawo 21E la Securities Exchange Act la 1934 (monga lasinthidwa).Simuyenera kudalira zonena zamtsogolo monga kulosera zamtsogolo.Ngakhale timakhulupirira kuti ziyembekezo zomwe zikuwonetsedwa m'mawu amtsogolo ndi zomveka, sitingatsimikizire kuti zotsatira zamtsogolo, milingo ya ntchito, magwiridwe antchito, zochitika, zochitika, kapena zopambana zomwe zikuwonetsedwa m'mawu amtsogolo zidzakwaniritsidwa kapena kuchitika.
Mawu amtsogolo amakhala ndi zoopsa komanso kusatsimikizika, zomwe zingapangitse zotsatira zenizeni kukhala zosiyana ndi zomwe timayembekezera.Zowopsa izi ndi kusatsimikizika kumakhudza, koma sizimangokhala: zotsatira, nthawi, mtengo, ndi kumaliza ntchito zathu za R&D ndi zivomerezo zowongolera, kuphatikiza kuchedwa kopitilira muyeso wa BLA wa FDA kuvomereza DaxibotulinumtoxinA jekeseni, pochiza mizere ya glabellar, kuphatikiza chifukwa cha zomwe a FDA adaziwona pakuwunika pamasamba kapena zifukwa zina;mliri wa COVID-19 wakakamiza bizinesi yathu yopanga zinthu, zogulitsira, zofuna za ogwiritsa ntchito kumapeto kwa zinthu zathu, zoyesayesa zamalonda, mabizinesi, mayeso azachipatala, ndi zina zabizinesi yathu ndi msika Titha kupanga zinthu zomwe timagula. ofuna ndikupeza zinthu za RHA® dermal filler series;mosatsimikizika matenda chitukuko ndondomeko;mayesero azachipatala sangakhale ndi mapangidwe ogwira mtima kapena kutulutsa zotsatira zabwino, kapena zabwino Zotsatirazi zidzatsimikizira chiopsezo cha kuvomerezedwa kwa malamulo kapena kupambana kwamalonda;kugwiritsidwa ntchito kwa kafukufuku wachipatala kumabweretsa zotsatira zenizeni;chiŵerengero ndi kuchuluka kwa phindu lazachuma, chitetezo, kuchita bwino, kuvomereza malonda, ndi OPUL™, RHA® dermal filler series ndi Msika wathu, mpikisano, kukula ndi kukula kwa chinthu chomwe mukufuna (ngati chivomerezedwa);kuthekera kwathu kupitiliza kugulitsa bwino mndandanda wa RHA® dermal filler ndi OPUL™, ndikutha kugulitsa bwino DaxibotulinumtoxinA ya jakisoni (ngati ivomerezedwa), ndi Nthawi ndi mtengo wazinthu zamalonda;luso lathu lokulitsa luso la malonda ndi malonda;Mkhalidwe wa mgwirizano wamalonda;kuthekera kwathu kupeza ndalama zogwirira ntchito zathu;mtengo wathu ndi kuthekera kwathu kodziteteza pamilandu yazinthu, katundu wanzeru ndi milandu ina;Tili ndi kuthekera kopitiliza kupeza ndi kusunga chitetezo chanzeru cha ofuna mankhwala;momwe timagwirira ntchito pazachuma, kuphatikiza ndalama zomwe timapeza m'tsogolo, zowonongera ndi zofunika zazikulu;ndi zoopsa zina.Kuti mumve zambiri pazifukwa zomwe zingapangitse kuti zotsatira zenizeni zisiyane ndi zomwe zafotokozedwa kapena zomwe zanenedwa m'nkhani ino, chonde onani zikalata zathu zomwe zimaperekedwa ku United States Securities and Exchange Commission (SEC), kuphatikiza zomwe zili mugawo lotchedwa. "Zowopsa" Zomwe zafotokozedwa mu "zinthu" pa Fomu 10-K zomwe tidapereka ku SEC pa February 25, 2021 zikuphatikiza koma sizimangokhala pa 10 kotala yomwe idatha pa Juni 30, 2021, yomwe tidapereka ku SEC. pa Ogasiti 5, 2021. -Q table.Mawu oyembekezera m'tsogolomu m'nkhani ino akugwira ntchito kuyambira tsiku lofalitsidwa.Sitikukakamizika kukonzanso ziganizo zamtsogolo izi.
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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Nthawi yotumiza: Oct-13-2021