Musi waJune 29,Intercept Pharmaceuticals yakaziviswakuti yakagamuchira mushonga mutsva wakazara kubva kuUS FDA maererano neFXR agonist obeticholic acid (OCA) yefibrosis inokonzerwa neiyo isiri doro steatohepatitis (NASH) Response tsamba (CRL).Iyo FDA yakataura muCRL kuti zvichibva pane data rakaongororwa kusvika pari zvino, inotenda kuti mabhenefiti anotarisirwa emushonga anoenderana neimwe histopathology miedzo yekupedzisira haisati yanyatso zivikanwa, uye mabhenefiti ekurapa haapfuure njodzi dzinogona kuitika, saka hazviite. tsigiro yakakwidziridza kubvumidzwa kweOCA kurapwa kweNASH Varwere vanokonzera chiropa fibrosis.

Mark Pruzanski, Mutungamiriri uye CEO weIntercept, yakataura pamusoro pemigumisiro: "Panguva yekuongorora, FDA haisati yambotaura ruzivo pamusoro pekukurumidza kubvumirwa kweOCA, uye tinotenda zvakasimba kuti data yose yakatumirwa kusvika zvino inosangana nezvinodiwa neFDA uye zvakajeka Tsigira njodzi yeOCA yepurofiti yakanaka.Tinodemba CRL iyi.Iyo FDA yakawedzera zvishoma nezvishoma kuoma kweiyo histological endpoints, nekudaro ichigadzira yakakwira chipingamupinyi chekupfuura.Kure kure,OCAiri muzvikamu zvitatu zvakakosha.Chikumbiro ichi chakazadzikiswa panguva yekudzidza.Isu tinoronga kusangana neFDA nekukurumidza sezvinobvira kuti tikurukure nzira yekupasa hurongwa hwemvumo paruzivo rweCRL mune ramangwana. "

Munhangemutange yekutora mushonga wekutanga wakanyorwa weNASH, Intercept yagara iri pachinzvimbo chekutungamira uye parizvino ndiyo yega kambani yakawana data rakanaka rekunonoka-danho rekuedza.Seyakasimba uye yakananga farnesoid X receptor (FXR) agonist,OCAakambowana mhedzisiro yakanaka muchikamu chechitatu chekiriniki chekuyedza chinonzi REGENERATE.Iyo data yakaratidza kuti pakati kusvika kune yakaoma NASH yakagamuchira madosi akakwira eOCAPakati pevarwere, chikamu chimwe muzvina chevarwere 'chiropa fibrosis zviratidzo zvakavandudzwa zvakanyanya, uye mamiriro acho haana kuderera.

Iyo FDA yakakurudzira kuti Intercept itumire yakawedzera kushanda kwechinguva uye kuchengetedza data kubva kuchirikuenderera REGENERATE kudzidza kutsigira.OCA kugonayakakurumidza kubvumidza, uye yakaratidza kuti mhedzisiro yenguva refu yechidzidzo inofanira kuenderera.

NyangweOCAyakambobvumidzwa kune imwe isingawanzo chiropa chirwere (PBC), munda weNASH wakakura.Inofungidzirwa kuti NASH inobata mamiriyoni evanhu muUnited States chete.Pakutanga, bhanga rekudyara JMP Securities raifungidzira kuti kutengesa kwepamusoro kweIntercept mishonga kunogona kusvika mabhiriyoni emadhora.Kukanganiswa nenhau dzakaipa idzi, mutengo weIntercept wakadonha ungangoita 40% nemusi weMuvhuro kusvika $47.25 per share.Mitengo yemitengo yemamwe makambani emishonga akagadzirawo NASH yadonhawo.Pakati pavo, Madrigal yakadonha nezvikamu zvitanhatu kubva muzana, uye Viking, Akero neGenFit yakadonha neinosvika 1%.

Muongorori weStifel Derek Archila akanyora mumushumo kumutengi kuti kuramba kwacho kwakakonzerwa nemhedzisiro ine chekuita nekurapa yakaitikaOCA kliniki yekuongorora, kureva kuti, vamwe varwere vakagamuchiraOCA kurapwa, iyo cholesterol inokuvadza mumuviri yakawedzera, izvo zvinozovaita kuti vave nehuwandu hwehuwandu hwehutano hwemwoyo.Tichifunga kuti varwere vazhinji veNASH vatove vakafuta kana kurwara nechirwere cheshuga cherudzi rwechipiri, mhedzisiro yakadaro inogona kumutsa kusvinura kwemasangano anodzora.Zvinoenderana nezvinodiwa neFDA kune yekuwedzera bvunzo data, Intercept inogona kumirira kusvika inokwana hafu yechipiri ya2022 kududzira aya data.Ongororo yekunze inotenda kuti kunonoka kwakadaro kunogona kudzima chikamu cheIntercept chakambounganidzwa lead, zvichibvumira vamwe vakwikwidzi vanosanganisira Madrigal Pharmaceuticals uye Viking Therapeutics kuwana mukana wekubata.