Ishoramari rizatera inkunga IGALMI upcoming ibikorwa byubucuruzi muri Amerika no guteza imbere imiyoboro y’amavuriro
HAVEN NSHYA, Conn., Ku ya 19 Mata 2022 (GLOBE NEWSWIRE) - BioXcel Therapeutics, Inc. isosiyete ihindura imiti muri neuroscience na immuno-oncology, uyu munsi yatangaje amasezerano yo gutera inkunga ingamba hamwe na Oaktree Capital Management, LP (“Oaktree”) n’amafaranga acungwa n’ikigo gishinzwe ishoramari cya Qatar (“QIA”). Muri ayo masezerano, Oaktree na QIA bazatanga agera kuri miliyoni 260 z'amadorali yo gutera inkunga yose yo gushyigikira ibikorwa by'ubucuruzi bya sosiyete IGALMI ™ (dexmedetomidine) ya sublingual membrane. Byongeye kandi, inkunga igamije gushyigikira ibikorwa byo guteza imbere amavuriro ya BXCL501, harimo na gahunda y'icyiciro cya 3 cyo kuvura bikabije yo guhagarika umutima mu barwayi ba Alzheimer (AD), hamwe n’umushinga w’inyongera w’ikigo n’umushinga w’ubuvuzi wa immuno-oncology.
Gahunda ndende yo gutera inkunga ingamba ziyobowe na Oaktree kandi ikubiyemo ibice bikurikira:
Muri ayo masezerano, BioXcel Therapeutics izemerwa n’ikigo cy’Amerika gishinzwe ibiryo n’ibiyobyabwenge (FDA) cyo gukoresha ibicuruzwa bya BXCL501 by’isosiyete mu kuvura cyane imvururu ziterwa na sikizofreniya cyangwa indwara ya bipolar I cyangwa II ku bantu bakuru.Iki kibazo cyujujwe kuri Ku ya 5 Mata 2022, nyuma yo kwemezwa na FDA kwa IGALMI.
Ibyingenzi byingenzi byatewe inkunga harimo umurongo wigihe cyinguzanyo gusa mugihe cyimyaka itanu hamwe na FDA byemejwe na BXCL501 kugirango bivure bikabije imvururu ziterwa n'indwara ya Alzheimer. , harimo na BXCL701, iperereza ry’isosiyete ikora iperereza mu kanwa kavukire. Mugihe hashingiwe ku masezerano y’amafaranga yinjira mu nyungu zinjira mu nyungu, Oaktree na QIA bazahabwa amafaranga yo kwishyura mu byiciro byinjira, hashingiwe ku gipimo kinini cyo kugaruka, ku kugurisha neza kwa IGALMI hamwe n’izindi zose zizaza BXCL501 ibicuruzwa muri Reta zunzubumwe zamerika.Ibipimo byo gutera inkunga inyungu biva kuri 0.375% kugeza 7.750% byumusaruro wumwaka wa IGALMI nibindi bicuruzwa bizaza BXCL501 muri Amerika Gucungura amasezerano yinguzanyo yinyungu kumubare muto mumyaka itatu yambere. ikubiyemo kandi ishoramari rishobora kugera kuri miliyoni 5 z'amadolari mu migabane rusange y’isosiyete, ku bushake bwa Oaktree na QIA, hashingiwe ku masezerano y'inguzanyo ku giciro kuri buri mugabane uhwanye na 10% premium hejuru ya 30% premium yatera Oaktree na / cyangwa QIA gukoresha amahitamo Buri munsi uburemere buringaniye igiciro.
Nyuma yo gusoza iki gikorwa, hamwe n’amafaranga asigaye y’isosiyete hamwe na gahunda y’ubucuruzi iteganijwe, BioXcel Therapeutics iteganya ko izagira imari shingiro y’imyaka myinshi.Irangizwa ry’iyi nkunga rizaha isosiyete inzira y’amafaranga mu 2025.
Umuyobozi mukuru wa BioXcel Therapeutics, Dr. Vimal Mehta yagize ati: "Nyuma yo kwemezwa na IGALMI ndetse n’itangazwa ry’uyu munsi, ntabwo twigeze duhagarara neza kugira ngo dushobore kugera ku cyerekezo cyacu cyo kuba sosiyete ikora ibijyanye n’ubumenyi bw’imyororokere mu buhanga".Yakomeje agira ati: "Twishimiye Gushimangira umwanya w'amafaranga cyane cyane hamwe n’igishoro kidahwitse mu gihe twitegura gutangiza IGALMI no guteza imbere ingamba zacu zo kuzamura inkingi eshatu kuri iyi francise, ikubiyemo gukurikirana ibindi bimenyetso, kwagura akarere kacu no kwagura ubuvuzi bwa IGALMI burahari .Hagati aho, dukomeje kwiyemeza guteza imbere ubumenyi bw’inyongera ndetse na immuno-oncology portfolio, harimo BXCL502 na BXCL701. ”
Aman Kumar, Co yagize ati: "Twishimiye gufatanya na BioXcel Therapeutics muri iki gihe kiri imbere cyo kuzamuka kwitezwe, cyane cyane kwemezwa vuba aha ndetse no guteganya ko hajyaho ubucuruzi bwa IGALMI nk'umuti ukaze w’imyivumbagatanyo ifitanye isano na sikizofreniya ikuze cyangwa indwara ya bipolar I cyangwa II". -Portfolio Manager wa Oaktree Life Science Lending. isi. ”
Andi makuru yerekeye gutera inkunga ingamba agaragara mu ifishi ya BioXcel Therapeutics Ifishi ya 8-K ishyikirizwa komisiyo ishinzwe kugurizanya no kugurizanya muri Amerika (SEC).
IGALMI (dexmedetomidine) filime ya sublingual, yahoze yitwa BXCL501, ni filime yigenga yo mu kanwa ishushanya ya dexmedetomidine yerekanwe ku buryo bukabije bwo kuvura abarwayi bafite sikizofreniya cyangwa indwara ya bipolar iyobowe n’ubuvuzi bukuze bujyanye n’indwara ya I cyangwa II. Umutekano n’ingirakamaro bya IGALMI ntabwo byashyizweho nyuma y’amasaha 24 nyuma y’igipimo cya mbere. Ku ya 5 Mata 2022, Ikigo cy’Amerika gishinzwe ibiryo n’ibiyobyabwenge (FDA) cyemeje IGALMI gishingiye ku mibare yatanzwe na pivotal ebyiri zitemewe, impumyi ebyiri, zigenzurwa na platbo .
BioXcel Therapeutics, Inc. ni isosiyete ikora ibijyanye n’ibinyabuzima ikoresha uburyo bw’ubwenge bw’ubuhanga mu guteza imbere imiti ihindura imitekerereze ya neuroscience na immuno-oncology. kwiga algorithms kugirango hamenyekane ibimenyetso bishya byo kuvura.Ibicuruzwa byubucuruzi byikigo IGALMI (byatejwe imbere nka BXCL501) nigikorwa cya firime dexmedetomidine sublingual firime yemewe na FDA kugirango ivure cyane ubukana bujyanye na sizizofrenia cyangwa indwara ya bipolar I cyangwa II mubantu bakuru .BXCL501 nayo. gusuzumwa kugirango bivurwe bikabije byindwara ya Alzheimer, kandi nkumuti wongeyeho indwara ikomeye yo kwiheba.Isosiyete kandi irimo guteza imbere BXCL502, uburyo bwo kuvura indwara zidakira ziterwa no guta umutwe, na BXCL701, iperereza, ryakozwe mu magambo rikoresha uburyo bwo gukingira indwara. kuvura kanseri ya prostate ikaze hamwe nibibyimba bikomeye byateye imbere, bikaba byanze bikunze cyangwa bitavuwe neza. Kubindi bisobanuro, sura kuri www.bioxceltherapeutics.com.
BofA Securities yakoze nk'umujyanama wihariye wubuyobozi bwa BioXcel Therapeutics na Cooley LLP yabaye umujyanama mu by'amategeko muri BioXcel Therapeutics.Sullivan & Cromwell LLP akora nk'umujyanama mu by'amategeko kuri Oaktree na Shearman & Sterling LLP ni umujyanama mu by'amategeko muri QIA.
Oaktree n’isosiyete ikora ibijyanye n’imicungire y’ishoramari ku isi izobereye mu ishoramari rindi, ifite miliyari 166 z’amadolari y’umutungo ucungwa guhera ku ya 31 Ukuboza 2021.Ikigo gishimangira uburyo bw’amahirwe, bushingiye ku gaciro kandi bugenzurwa n’inguzanyo ku nguzanyo, imigabane y’abikorera, n’umutungo utimukanwa. gushora.ibicuruzwa hamwe nububiko byashyizwe ku rutonde. Isosiyete ifite abakozi n’ibiro birenga 1.000 mu mijyi 20. Kwisi. Ushaka amakuru menshi, sura urubuga rwa Oaktree kuri http://www.oaktreecapital.com/.
Ikigo gishinzwe ishoramari cya Qatar (“QIA”) n’ikigega cy’ubutunzi cyigenga cya Leta ya Qatar.QIA yashinzwe mu 2005 kugira ngo ishore imari kandi icunge ikigega cy’igihugu cy’igihugu. QIA ni imwe mu kigega kinini kandi gikora cyane ku mutungo wigenga ku isi. QIA ishora imari mubyiciro byinshi byumutungo hamwe nubutaka kandi ikorana ninzego zikomeye ku isi kubaka portfolio itandukanye ku isi ifite icyerekezo kirekire cyo gutanga umusaruro urambye no gutanga umusanzu mu iterambere rya Qatar.Ku makuru arambuye kuri QIA, nyamuneka sura urubuga rwayo www.qia.qa.
Iri tangazo rigenewe abanyamakuru ririmo "amagambo-areba imbere" mu bisobanuro by'Itegeko rigenga ivugurura ry'imanza bwite z’abikorera ku giti cyabo ryo mu 1995. Amagambo yo kureba imbere muri iri tangazo arimo, ariko ntagarukira gusa: gutangiza ubucuruzi bwa IGALMI muri Amerika kugira ngo bivure imidugararo muri abarwayi bafite schizofrenia n'indwara ya bipolar;gahunda ziterambere ryamavuriro, harimo niterambere ryisosiyete ikomeje guteza imbere BXCL501, yo kuvura abarwayi bafite ikibazo cyo guta umutwe kandi nkumuti uhuza indwara zikomeye zo kwiheba;gahunda ziterambere ryikigo;inkunga iteganijwe hashingiwe ku masezerano yagiranye na Oaktree na QIA hamwe n’umuhanda ugereranya amafaranga y’isosiyete kandi biteganijwe ko umutungo w’isosiyete uhagije uhagije. Iyo ukoresheje hano, amagambo arimo “gutegereza,” “ubushake,” “gahunda,” “ubushobozi,” “birashoboka,” "Komeza," "ugambiriye," "igishushanyo," "intego," kandi imvugo isa nayo isobanura Mu kumenya imvugo-ireba imbere. Byongeye kandi, amagambo cyangwa amakuru ayo ari yo yose, harimo ibitekerezo byose bifatika, bijyanye n'ibiteganijwe, imyizerere, gahunda, iteganyagihe. , intego, imikorere cyangwa ibindi biranga ibizaba cyangwa ibihe bizaza, bireba imbere.Ibintu byose bireba imbere bishingiye kubyo sosiyete iteganya muri iki gihe n'ibitekerezo bitandukanye. Isosiyete yizera ko ibyo iteganya n'imyizerere bifite ishingiro ryumvikana, ariko ni byo muburyo budashidikanywaho.Isosiyete ntishobora kubahiriza ibyo iteganya, kandi imyizerere yayo ntishobora kwerekana ko ari ukuri.Ibisubizo nyabyo birashobora gutandukana mubintu bitandukanye nibisobanuwe cyangwa byerekanwe namagambo areba imbere bitewe nibintu bitandukanye byingenzi, harimo, ariko, ntibigarukira gusa: Isosiyete ikeneye igishoro cyinyongera nubushobozi bwayo bwo gushora imari nibisabwa;FDA hamwe n’abayobozi b’amahanga basa na gahunda yo kwemeza amabwiriza ni ndende, itwara igihe, ihenze kandi isanzwe idateganijwe;isosiyete ifite uburambe buke mu kuvumbura ibiyobyabwenge no guteza imbere ibiyobyabwenge;abagenzuzi ntibashobora kwemera cyangwa kwemeranya nibitekerezo byikigo, ibigereranyo, kubara, imyanzuro cyangwa isesengura, cyangwa birashobora Akamaro ko gusobanura cyangwa gupima amakuru muburyo butandukanye, bushobora kugira ingaruka kumikorere ya gahunda runaka, kwemeza cyangwa gucuruza ibicuruzwa runaka umukandida wibicuruzwa cyangwa ibicuruzwa nisosiyete muri rusange;isosiyete idafite uburambe mu kwamamaza no kugurisha imiti kandi nta burambe ifite kuri IGALMI cyangwa BXCL501 yo kugurisha no kwamamaza;IGALMI cyangwa abandi bakandida b'isosiyete ntibashobora kwemerwa n'abaganga cyangwa umuryango rusange w'ubuvuzi;Isosiyete ntishobora kubona ibyemezo byo kwamamaza kuri BXCL501 i Burayi cyangwa izindi nkiko;Isosiyete irashobora gusaba igishoro kinini cyinyongera kugirango itezimbere kandi ikore ibizamini bya Clinical bifitanye isano nabakandida bayo ibicuruzwa no gushyigikira ibikorwa byabo;ibigo bigomba kubahiriza amategeko menshi akurikizwa;ivugurura ry’ubuzima rishobora kugira ingaruka mbi ku iterambere ry’ubucuruzi mu gihe kizaza.Ibindi bintu by’ingenzi byaganiriweho ku mutwe wa “Risk Factors” muri Raporo Y’umwaka ku Ifishi ya 10-K y'umwaka urangiye ku ya 31 Ukuboza 2021, kuko ibyo bintu bishobora kugaragara rimwe na rimwe mu zindi dosiye zayo hamwe namakuru agezweho ya SEC, aboneka kurubuga rwa SEC kuri www.sec.gov.Ibindi nibindi bintu byingenzi bishobora gutuma ibisubizo nyabyo bitandukana mubintu bitandukanye nibyerekanwe namagambo areba imbere muri iri tangazo.Buriya bose imbere -inyandiko zireba zerekana igereranyo cyubuyobozi guhera kumunsi yatangarijweho itangazamakuru.Nubwo isosiyete ishobora guhitamo kuvugurura ayo magambo areba imbere mugihe runaka kizaza, usibye nkuko amategeko abiteganya, iramagana inshingano zose zo kubikora, kabone niyo byaba ibyakurikiyeho bituma ibitekerezo byacu bihinduka. Aya magambo areba imbere ntagomba kumvikana nkuhagarariye ibitekerezo byikigo kumunsi uwariwo wose nyuma yitariki yatangarijweho.
1 Inkunga ikubiyemo kandi impapuro zo kugura imigabane y’imigabane rusange y’isosiyete ndetse n’icyemezo cyo kugura ibice by’ishami ry’isosiyete LLC, nkuko byasobanuwe neza muri raporo iriho ubu ku ifishi ya 8-K izatangwa ku ya 19 Mata 2022.
Igihe cyo kohereza: Gicurasi-07-2022