Nashville, Tennessee, Gumiguru 12, 2021–(BUSINESS WIRE)–Revance Therapeutics, Inc. (NASDAQ: RVNC) ikambani yebiotechnology yakatarisana neruzivo rwekunakisa uye mishonga yekurapa.Yakapindura kune chikumbiro cheRusununguko rweRuzivo rweRuzivo (FOIA) pamusoro peFDA mukupindura kuburitswa pachena kweFomu 483. Iyo Biologics Licensing Application (BLA) yeDaxibotulinumtoxinA yejekiseni ichiri pasi pekuongorora kweFDA, uye kambani inoramba ichitarisira FDA. kubvumidza DaxibotulinumtoxinA yejekiseni yekurapa mitsetse yakafinyama muna 2021.
Revance akataura kuti hazvishamisi kuti Fomu 483 ripihwe mushure mekuongororwa kwenzvimbo.Fomu 483 inonyora zvakaonekwa nemumiriri weFDA panguva yekuongorora nzvimbo.Fomu 483 haiumbe sarudzo yekupedzisira yeamiririri.
Revance yakapindura kuFomu 483 muna Chikunguru 2021 mushure mekuongorora kusati kwabvumidzwa uye parizvino yakamirira danho reFDA paBLA yeDaxibotulinumtoxinA yejekiseni rekurapwa kwemitsara yeglabellar.Iyo kambani inoramba ichivimba nemhando yeBLA yayatumira uye inoramba ichitarisira kuti FDA iwane mvumo muna 2021.
Revance ikambani yebiotechnology yakatarisana nehunyanzvi hwekunakisa uye mishonga yekurapa, kusanganisira yayo inotevera-chizvarwa neuromodulator chigadzirwa DaxibotulinumtoxinA yeJekiseni.DaxibotulinumtoxinA yejekiseni inosanganisa proprietary yakagadzikana peptide excipient uye yakanyatsocheneswa botulinum toxin isina vanhu kana mhuka.Revance yakabudirira kupedzisa chikamu chechitatu cheDaxibotulinumtoxinA yejekiseni remukati (kufinyamisa), uye iri kutsvaga mvumo kubva kuUS regulatory agency.Revance iri kuongororawo DaxibotulinumtoxinA yemajekiseni pamusoro pechiso chepamusoro, kusanganisira mitsetse yeglabellar, mitsetse yehuma, uye tsoka dzegunguo, pamwe chete nezviratidzo zviviri zvekurapa-cervical dystonia uye mukuru wepamusoro wemakumbo spasm.Kuti tibatane neDaxibotulinumtoxinA yejekiseni, Revance ine nhevedzano yezvakasiyana zvemhando yepamusoro zvigadzirwa uye masevhisi anoshandiswa muAmerican runako kudzidzira, kusanganisira iyo yakasarudzika kodzero yekugovera yeRHA® dermal filler series muUnited States.Iyi ndiyo yekutanga uye yega yakatenderwa neFDA kuti ishandiswe muMutsetse wemafirita ane simba kugadzirisa kumeso nekupeta, uye OPUL™ hukama bhizinesi chikuva.Revance yakabatana zvakare neViatris (yaimbova Mylan NV) kugadzira biosimilar yeBOTOX®, iyo inokwikwidza mumusika uripo unobata neuromodulator musika.Revance yakazvipira kushandura mamiriro equo nekushandura ruzivo rwemurwere.Kuti uwane rumwe ruzivo kana kujoinha timu yedu, ndapota shanya www.revance.com.
Chero zvirevo zviri mupepanhau rino zvakaburitswa zvisiri zvirevo zvezvakaitika kare, kusanganisira zvirevo zvine chekuita nekugona kwedu uye nguva yekuwana mvumo yeFDA yeBLA ye botulinum toxin A yejekiseni rekurapa mitsetse yakaunyana;kunaka kweBLA yedu yekutumira Yakazara nechivimbo;yedu yekutumira BLA mamiriro;FDA yekuongorora mhedzisiro yezvivakwa zvekugadzira zvekambani muNorth California, uye mhedzisiro yekuvandudzwa kweBOTOX® biosimilars nemumwe wedu Viatris;inoumba "Private Securities Litigation Reform Act ya1995", "1933-inotarisisa zvirevo mukati mezvinoreva Chikamu 27A cheSecurities Act ye1934 (seyakagadziriswa) uye Chikamu 21E cheSecurities Exchange Act ya1934 (seyakagadziridzwa).Haufanire kuvimba nezvirevo zvinomirira mberi sekufanotaura kwezvichaitika mune ramangwana.Kunyange zvazvo tichitenda kuti zvinotarisirwa zvinoratidzwa mumashoko anotarisa mberi zvine musoro, hatigoni kuvimbisa kuti migumisiro yeramangwana, mazinga emabasa, maitiro, zviitiko, mamiriro ezvinhu, kana kubudirira kunoratidzwa mumashoko ekutarisira mberi zvichagara zvichionekwa kana kuitika.
Matauriro anotarisisa mberi ari pasi penjodzi uye kusava nechokwadi, izvo zvinogona kuita kuti mhedzisiro chaiyo isiyane kubva pane zvatinotarisira.Njodzi idzi uye kusava nechokwadi zvinosanganisira, asi hazvigumiri pa: mhedzisiro, nguva, mutengo, uye kupedzwa kwezviitwa zvedu zveR&D uye kubvumidzwa kwemitemo, kusanganisira kuenderera mberi kwekunonoka mukubvumidzwa kweFDA's BLA yeDaxibotulinumtoxinA yejekiseni, kurapwa kwemitsara yeglabellar, kusanganisira nekuda kwekuonekwa kweFDA panguva yekuongorora-saiti kana zvimwe zvikonzero;denda reCOVID-19 rakaisa bhizinesi redu rekugadzira, cheni yekugovera, kudiwa kwevashandisi vekupedzisira kwezvigadzirwa zvedu, kuedza kwekutengesa, mashandiro ebhizinesi, miedzo yekiriniki, uye zvimwe zvinhu zvebhizinesi redu nemusika Tinokwanisa kugadzira zvinhu zvechigadzirwa chedu. vakwikwidzi uye vawane zvekushandisa zveRHA® dermal filler series;kusava nechokwadi kwekiriniki yekuvandudza nzira;miedzo yekiriniki inogona kunge isina dhizaini inoshanda kana kuburitsa mhedzisiro yakanaka, kana yakanaka Mhedzisiro ichaita kuti njodzi yekubvumidzwa kwemutemo kana kubudirira kwekutengeserana;kushanda kwekutsvakurudza kwekliniki kunoguma kune migumisiro chaiyo;chiyero uye dhigirii rekubatsira kwehupfumi, kuchengetedzeka, kubudirira, kugamuchirwa kwekutengeserana, uye OPUL™, RHA® dermal filler series uye yedu Musika, makwikwi, chiyero uye kukura kwechigadzirwa chemumiriri (kana chakabvumidzwa);kugona kwedu kuenderera mberi nekubudirira kushambadzira iyo RHA® dermal filler series uye OPUL™, uye kukwanisa kutengeserana kubudirira DaxibotulinumtoxinA yejekiseni (kana yakabvumirwa), uye Nguva uye mari yezviitwa zvekutengesa;kugona kwedu kuwedzera kutengesa nekutengesa kugona;chimiro chekushandira pamwe kwebhizinesi;kukwanisa kwedu kuwana mari yekushanda kwedu;mutengo wedu uye kugona kuzvidzivirira pamhosva yechigadzirwa, pfuma yehungwaru uye dzimwe nyaya;Isu tine kugona kuenderera mberi nekuwana nekuchengetedza kuchengetedzwa kwepfuma yevanoda zvinodhaka;kuita kwedu kwemari, kusanganisira mari yeramangwana, mari inoshandiswa uye mari inodiwa;nedzimwe njodzi.Kuti uwane ruzivo pamusoro pezvinhu zvinogona kuita kuti mhedzisiro chaiyo isiyane kubva kune yakataurwa kana kutaurwa mune ino kuburitswa kwenhau, ndapota tarisa kumagwaro edu enguva dzose akaiswa kuUnited States Securities and Exchange Commission (SEC), kusanganisira iwo ari muchikamu chakanzi. "Njodzi" Zvinhu zvinotsanangurwa mu "zvinhu" paFomu 10-K zvatakaisa kuSEC musi waKukadzi 25, 2021 zvinosanganisira asi hazvina kugumira kugumi rekota rakapera June 30, 2021, iro ratakaisa kuSEC. musi waNyamavhuvhu 5, 2021. -Q tafura.Mashoko anotarisa mberi mune ino nhepfenyuro anongoshanda kubva pazuva rekuburitswa.Isu hatiite chero chisungo chekuvandudza izvi zvinotarisisa zvirevo.
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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Nguva yekutumira: Oct-13-2021