I-Nashville, Tennessee, Okthoba 12, 2021–(INTAMBO YEBHIZINISI)–Revance Therapeutics, Inc. (NASDAQ: RVNC) yinkampani ye-biotechnology egxile ekusungulweni kobuhle nemikhiqizo yokwelapha.Iphendule esicelweni se-Freedom of Information Act (FOIA) ngokumelene ne-FDA ngokuphendula ukudalulwa komphakathi kweFomu 483. Isicelo Selayisense Ye-Biologics (BLA) ye-DaxibotulinumtoxinA yomjovo sisangaphansi kokubuyekezwa kwe-FDA, futhi inkampani iyaqhubeka nokulindela i-FDA. ukugunyaza i-DaxibotulinumtoxinA yomjovo wokwelapha imigqa eshwabene ngo-2021.
URevance uveze ukuthi akuvamile ukuthi iFomu 483 likhishwe ngemuva kokuhlolwa endaweni.IFomu 483 libala ukubonwa okwenziwa omele i-FDA ngesikhathi sokuhlolwa kwesikhungo.Ifomu 483 alisona isinqumo sokugcina se-ejensi.
I-Revance iphendule kuFomu 483 ngoJulayi 2021 ngemuva kokuhlolwa kwangaphambilini kokugunyazwa futhi okwamanje ilinde isinqumo se-FDA nge-BLA ye-DaxibotulinumtoxinA yomjovo wokwelapha imigqa ye-glabellar.Inkampani ihlezi iqiniseka ngekhwalithi yokuthunyelwa kwe-BLA futhi iyaqhubeka nokulindela ukuthi i-FDA ithole imvume ngo-2021.
I-Revance yinkampani ye-biotechnology egxile emikhiqizweni emisha yobuhle neyokwelapha, okuhlanganisa umkhiqizo wayo wesizukulwane esilandelayo se-neuromodulator i-DaxibotulinumtoxinA Yomjovo.I-DaxibotulinumtoxinA yomjovo ihlanganisa isakhi se-peptide esizinzile kanye nobuthi be-botulinum obuhlanzwe kakhulu ngaphandle kwezingxenye zomuntu noma zezilwane.I-Revance isiqede ngempumelelo isigaba sesithathu se-DaxibotulinumtoxinA yokujova e-intra-brow (frown), futhi ifuna imvume kuma-ejensi alawulayo ase-US.I-Revance iphinde ihlole i-DaxibotulinumtoxinA yokujova ebusweni obungaphezulu, okuhlanganisa imigqa ye-glabellar, imigqa yasebunzini, nezinyawo zegwababa, kanye nezinkomba ezimbili zokwelapha-i-dystonia yomlomo wesibeletho kanye ne-spasm yabantu abadala engaphezulu.Ukuze usebenzisane ne-DaxibotulinumtoxinA yokujova, i-Revance inochungechunge lwemikhiqizo ehlukile yekhwalithi ephezulu kanye nezinsizakalo ezisetshenziswa ezenzweni zobuhle baseMelika, okuhlanganisa namalungelo akhethekile okusabalalisa ochungechunge lwe-RHA® dermal filler e-United States.Lena eyokuqala neyodwa kuphela egunyazwe i-FDA ukuthi isetshenziswe Ochungechungeni lwezigcwalisi ezinamandla ukuze kulungiswe imibimbi nokugoqeka kobuso, kanye nenkundla yebhizinisi lobudlelwano be-OPUL™.I-Revance iphinde yabambisana ne-Viatris (ngaphambili eyayiyi-Mylan NV) ukuthuthukisa i-biosimilar ye-BOTOX®, ezoqhudelana nemakethe ye-neuromodulator esebenza isikhathi esifushane.I-Revance izinikele ekuguquleni isimo esikhona ngokushintsha okuhlangenwe nakho kwesiguli.Ukuze uthole ulwazi olwengeziwe noma ukujoyina iqembu lethu, sicela uvakashele ku-www.revance.com.
Noma yiziphi izitatimende kulokhu kukhululwa kwabezindaba ezingezona izitatimende zamaqiniso omlando, okuhlanganisa izitatimende ezihlobene nekhono lethu nesikhathi sokuthola imvume ye-FDA ye-BLA yobuthi be-botulinum A bomjovo wokwelapha imigqa eshwabene;ikhwalithi yezicelo zethu ze-BLA Egcwele ukuzethemba;isimo sethu sokuthumela i-BLA;Imiphumela yokuhlolwa kwe-FDA yezindawo zokukhiqiza zenkampani eNyakatho California, kanye nemiphumela yokuthuthukiswa kwe-BOTOX® biosimilars nozakwethu i-Viatris;hlanganisa “uMthetho Wokuguqulwa Kwamacala Ezibambiso Eziyimfihlo ka-1995”, “Izitatimende ezibheke phambili zango-1933 ngaphakathi kwencazelo yeSigaba 27A soMthetho Wezokuphepha ka-1934 (njengoba uchitshiyelwe) kanye neSigaba 21E soMthetho Wokuhwebelana Ngezibambiso ka-1934 (njengoba uchitshiyelwe).Akufanele uthembele ezitatimendeni ezibheke phambili njengezibikezelo zezenzakalo zesikhathi esizayo.Nakuba sikholelwa ukuthi okulindelekile okubonakala ezitatimendeni zokubheka phambili kunengqondo, asikwazi ukuqinisekisa ukuthi imiphumela yesikhathi esizayo, amaleveli omsebenzi, ukusebenza, izehlakalo, izimo, noma impumelelo eboniswa ezitatimendeni zokubheka phambili zizohlala zigcwaliseka noma zenzeka.
Izitatimende ezibheke phambili zingaphansi kwezingozi nokungaqiniseki, okungase kubangele imiphumela yangempela yehluke kakhulu kulokho esikulindele.Lezi zingozi nokungaqiniseki kuhilela, kodwa azikhawulelwe kulokhu: imiphumela, isikhathi, izindleko, nokuqedwa kwemisebenzi yethu ye-R&D kanye nokugunyazwa kokulawula, okuhlanganisa ukubambezeleka okuqhubekayo ekugunyazweni kwe-FDA kwe-BLA ye-DaxibotulinumtoxinA yomjovo, yokwelapha imigqa ye-glabellar, kuhlanganise ngenxa yokubhekwa kwe-FDA ngesikhathi sokuhlolwa kwendawo noma ezinye izizathu;ubhubhane lwe-COVID-19 lubeke ebhizinisini lethu lokukhiqiza, uchungechunge lokuhlinzeka, isidingo sabasebenzisi bokugcina bemikhiqizo yethu, imizamo yokuthengisa, ukusebenza kwebhizinisi, ukuhlolwa kwemitholampilo, kanye nezinye izici zebhizinisi lethu kanye nemakethe Sinekhono lokukhiqiza izimpahla zomkhiqizo wethu. amakhandidethi futhi bathole izinsiza zochungechunge lwe-RHA® dermal filler;inqubo yokuthuthukiswa komtholampilo engaqinisekile;ukuhlolwa kwemitholampilo kungase kungabi nemiklamo ephumelelayo noma kukhiqize imiphumela emihle, noma emihle Imiphumela izoqinisekisa ubungozi bokugunyazwa ngokomthetho noma impumelelo yokuhweba;ukusebenza kwemiphumela yocwaningo lomtholampilo emiphumeleni yangempela;isilinganiso nezinga lezinzuzo zezomnotho, ukuphepha, ukusebenza kahle, ukwamukelwa kwezentengiselwano, kanye nochungechunge lwe-OPUL™, RHA® dermal filler kanye nemakethe yethu, ukuncintisana, isikali namandla okukhula omkhiqizo wekhandidethi (uma kuvunyiwe);ikhono lethu lokuqhubeka nokuthengisa ngempumelelo uchungechunge lwe-RHA® dermal filler kanye ne-OPUL™, kanye nekhono lokuthengisa ngempumelelo i-DaxibotulinumtoxinA yomjovo (uma kuvunyiwe), kanye nesikhathi nezindleko zemisebenzi yokuthengisa;ikhono lethu lokwandisa amakhono okuthengisa nawokuthengisa;isimo sokubambisana kwebhizinisi;ikhono lethu lokuthola imali yokusebenza kwethu;izindleko zethu kanye nekhono lethu lokuzivikela esikweletini somkhiqizo, impahla yengqondo nezinye izimangalo;Sinekhono lokuqhubeka nokuthola kanye nokugcina ukuvikelwa kwempahla eqanjiwe yabantu abakhetha izidakamizwa;ukusebenza kwethu kwezezimali, okuhlanganisa imali engenayo yesikhathi esizayo, izindleko kanye nezidingo zemali;nezinye izingozi.Ukuze uthole imininingwane ngezinto ezingabangela imiphumela yangempela yehluke kakhulu kuleyo eshiwo noma eshiwo esitatimendeni kulokhu kukhululwa kwabezindaba, sicela ubheke amadokhumenti ethu avamile afakwe ne-United States Securities and Exchange Commission (SEC), kuhlanganise nalawo asesigabeni esinesihloko esithi. “Ingozi” Izinto ezichazwe “ezicini” zeFomu 10-K esizifake ku-SEC ngoFebhuwari 25, 2021 zibandakanya kodwa azikhawulelwe ngomhlaka-10 wekota ephele ngomhla ka-30 Juni 2021, esizifake ku-SEC. ngo-Agasti 5, 2021. -Q ithebula.Izitatimende ezibheke phambili kulokhu kukhululwa kwabezindaba zisebenza kuphela kusukela ngedethi yokushicilela.Asenzi noma yisiphi isibopho sokubuyekeza lezi zitatimende ezibheke 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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