Nashville, Tennessee, Okthobha 12, 2021–(INTAMBO YOSHISHINO)–Revance Therapeutics, Inc. (NASDAQ: RVNC) yinkampani yebiotechnology egxile kwi-aesthetics entsha kunye neemveliso zonyango.Iphendule kwisicelo soMthetho weNkululeko yoLwazi (FOIA) ngokuchasene ne-FDA ekuphenduleni ukubhengezwa koluntu kweFom 483. Isicelo seLayisensi ye-Biologics (BLA) ye-DaxibotulinumtoxinA ye-injection isaphantsi kohlaziyo lwe-FDA, kwaye inkampani iyaqhubeka ilindele i-FDA. ukuvuma i-DaxibotulinumtoxinA yenaliti yonyango lwemigca efingiweyo ngo-2021.
U-Revance ubonise ukuba akuqhelekanga ukuba iFomu 483 ikhutshwe emva kokuhlolwa kwendawo.IFomu 483 idwelisa imigqaliselo eyenziwe ngummeli we-FDA ngexesha lokuhlolwa kweziko.IFomu 483 ayenzi sigqibo sokugqibela se-arhente.
I-Revance iphendule kwiFomu 483 ngoJulayi 2021 emva kokuhlolwa kwangaphambili kokuvunywa kwaye okwangoku ilindele isigqibo se-FDA kwi-BLA ye-DaxibotulinumtoxinA yokujova unyango lwemigca ye-glabellar.Inkampani ihlala iqinisekile kumgangatho wokungeniswa kwe-BLA kwaye iyaqhubeka nokulindela ukuba i-FDA ifumane imvume ngo-2021.
I-Revance yinkampani ye-biotechnology egxile kwi-aesthetic entsha kunye neemveliso zonyango, kubandakanywa nesizukulwana esilandelayo semveliso ye-neuromodulator DaxibotulinumtoxinA ye-Injection.I-DaxibotulinumtoxinA yenaliti idibanisa i-excipient ye-peptide ezinzileyo kunye ne-toxin ye-botulinum ecocwe kakhulu ngaphandle kwezinto zabantu okanye izilwanyana.I-Revance igqibe ngempumelelo isigaba sesithathu se-DaxibotulinumtoxinA ye-intra-brow (frown) injection, kwaye ifuna imvume kwii-arhente ezilawulayo zase-US.I-Revance iphinda ivavanye i-DaxibotulinumtoxinA yeenaliti kubuso obungaphezulu, kubandakanywa imigca ye-glabellar, imigca yebunzi, kunye neenyawo ze-crow, kunye nezibonakaliso ezimbini zonyango-i-dystonia yomlomo wesibeleko kunye ne-spasm yabantu abadala.Ukuze usebenzisane ne-DaxibotulinumtoxinA ye-injection, i-Revance inoluhlu lweemveliso ezizodwa ezikumgangatho ophezulu kunye neenkonzo ezisetyenziswa kwi-American beauty practice, kubandakanywa namalungelo akhethekileyo okusasazwa kwe-RHA® dermal filler series e-United States.Le yeyokuqala nekuphela kwayo eyamkelwe yi-FDA ukuba isetyenziswe kuthotho lwezihluzi eziguquguqukayo ukulungisa imibimbi yobuso nokugotywa, kunye neqonga leshishini lobudlelwane be-OPUL™.I-Revance iye yasebenzisana ne-Viatris (eyayingu-Mylan NV) ukuphuhlisa i-biosimilar ye-BOTOX®, eya kukhuphisana kwi-market-acting neuromodulator market.I-Revance izinikele ekutshintsheni imeko ngokutshintsha amava esigulane.Ngolwazi oluthe kratya okanye ukujoyina iqela lethu, nceda undwendwele www.revance.com.
Naziphi na iinkcazo kolu shicilelo lweendaba ezingezizo iinkcazo zeenyaniso zembali, kubandakanywa iinkcazo ezinxulumene nokukwazi kwethu kunye nexesha lokufumana imvume ye-FDA ye-BLA ye-botulinum toxin A yokutofa unyango lwemigca efingiweyo;umgangatho weengxelo zethu ze-BLA ezigcwele ukuzithemba;isimo sethu sokungeniswa kwe-BLA;Iziphumo zokuhlolwa kwe-FDA yeendawo zokuvelisa zenkampani eNyakatho yeCalifornia, kunye neziphumo zophuhliso lweBOTOX® biosimilars kunye neqabane lethu leViatris;zenza "uMthetho woHlaziyo lweZibambiso zaBucala ka-1995", "iingxelo ezijonge phambili ngo-1933 ngaphakathi kwentsingiselo yeCandelo lama-27A loMthetho wezoKhuseleko ka-1934 (njengoko ulungisiwe) kunye neCandelo lama-21E loMthetho woTshintshiselwano lweZibambiso we-1934 (njengoko ulungisiwe).Akufunekanga uthembele kwiingxelo ezijonge phambili njengoqikelelo lweziganeko ezizayo.Nangona sikholelwa ukuba ukulindela okubonakaliswe kwiingxelo ezikhangele phambili kunengqiqo, asikwazi ukuqinisekisa ukuba iziphumo ezizayo, amanqanaba omsebenzi, ukusebenza, iziganeko, iimeko, okanye impumelelo ebonakaliswe kwiingxelo ezikhangele phambili ziya kuhlala zizaliseka okanye zenzeke.
Iingxelo ezijonge phambili zixhomekeke kumngcipheko kunye nokungaqiniseki, okunokubangela ukuba iziphumo zokwenyani zahluke ngokwezinto esizilindeleyo.Le mingcipheko kunye nokungaqiniseki kubandakanya, kodwa akukhawulelwanga: iziphumo, ixesha, iindleko, kunye nokugqitywa kwemisebenzi yethu ye-R & D kunye nokuvunyelwa kokulawula, kubandakanywa nokulibaziseka okuqhubekayo kwi-FDA's BLA imvume ye-DaxibotulinumtoxinA yokujova, ukwenzela unyango lwemigca ye-glabellar, kubandakanywa ngenxa yokuqwalaselwa kwe-FDA ngexesha lokuhlolwa kwendawo okanye ezinye izizathu;Ubhubhani we-COVID-19 unyanzelise ishishini lethu lokuvelisa, ikhonkco lonikezelo, imfuno yabasebenzisi bokuphela kweemveliso zethu, iinzame zokurhweba, ukusebenza kweshishini, ulingo lwezonyango, kunye neminye imiba yeshishini lethu kunye nentengiso Sinamandla okwenza iimpahla zemveliso yethu. abaviwa kwaye bafumane izibonelelo ze-RHA® dermal filler series;inkqubo yophuhliso lweklinikhi engaqinisekanga;izilingo zeklinikhi zingenako ukuyila okusebenzayo okanye ukuvelisa iziphumo ezilungileyo, okanye ezilungileyo Iziphumo ziya kuqinisekisa umngcipheko wokuvunyelwa kolawulo okanye impumelelo yorhwebo;ukusetyenziswa kweziphumo zophando lweklinikhi kwiziphumo zangempela;umlinganiselo kunye neqondo leenzuzo zoqoqosho, ukhuseleko, impumelelo, ukwamkelwa korhwebo, kunye ne-OPUL™, i-RHA® dermal filler series kunye neyethu Imarike, ukhuphiswano, isikali kunye namandla okukhula kwemveliso yomviwa (ukuba ivunyiwe);ukukwazi kwethu ukuqhubeka nokuthengisa ngempumelelo i-RHA® dermal filler series kunye ne-OPUL™, kunye nokukwazi ukuthengisa ngempumelelo i-DaxibotulinumtoxinA ye-injection (ukuba ivunyiwe), kunye nexesha kunye neendleko zemisebenzi yokuthengisa;amandla ethu okwandisa amandla okuthengisa kunye nokuthengisa;ubume bentsebenziswano kushishino;amandla ethu okufumana imali yokwenza imisebenzi yethu;iindleko zethu kunye nokukwazi ukuzithethelela kubutyala kwimveliso, kwipropathi enomgangatho ophezulu wokuqonda kunye nezinye izimangalo;Sinako ukuqhubeka nokufumana kwaye sigcine ukhuseleko lwepropathi yomenzi wechiza yabagqatswa bethu bamachiza;ukusebenza kwethu kwezemali, kubandakanywa umvuzo wexesha elizayo, iindleko kunye neemfuno zenkunzi;kunye nezinye iingozi.Ukufumana iinkcukacha malunga nezinto ezinokubangela ukuba iziphumo zokwenyani zahluke ngokwezinto ezibonakalayo kwezo zichazwe okanye zichazwe kwiingxelo ezikolu shicilelo lweendaba, nceda ujonge kumaxwebhu ethu aqhelekileyo afakwe kwiKhomishini yeSecurities and Exchange yase-United States (SEC), kubandakanywa nalawo akwicandelo elinesihloko. "Umngcipheko" Izinto ezichazwe "kwizinto" kwiFomu ye-10-K esiyifake kwi-SEC ngoFebruwari 25, 2021 ibandakanya kodwa ayiphelelanga kwi-10 yekota ephele nge-30 kaJuni 2021, esiyifake kwi-SEC. ngo-Agasti 5, 2021. -Q itheyibhile.Iingxelo ezijonge phambili kule ngxelo yeendaba zisebenza kuphela ukusuka ngomhla wokupapashwa.Asithathi naluphi na uxanduva lokuhlaziya ezi ngxelo zijonge phambili.
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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Ixesha lokuposa: Oct-13-2021