NgoJuni 29,I-Intercept Pharmaceuticals yabhengezwaukuba ifumene isicelo esitsha sechiza esipheleleyo esivela kwi-US FDA malunga ne-FXR agonist obeticholic acid (OCA) ye-fibrosis ebangelwa yi-non-alcoholic steatohepatitis (NASH) Incwadi yokuphendula (CRL). I-FDA ichaze kwi-CRL ukuba ngokusekwe kwidatha ephononongiweyo ukuza kuthi ga ngoku, ikholelwa ukuba izibonelelo ezilindelekileyo zechiza ezisekelwe kwezinye iziphelo zolingo lwe-histopathology azikaqinisekwa, kwaye iingenelo zonyango azigqithisi kwiingozi ezinokwenzeka, ngoko ke ayiqiniseki. inkxaso ekhawulezileyo ukuvunywa kwe-OCA kunyango lwe-NASH Izigulana ezibangela i-fibrosis yesibindi.

UMark Pruzanski, uMongameli kunye ne-CEO ye-Intercept, igqabaza ngeziphumo: "Ngexesha lenkqubo yokuphonononga, i-FDA ayizange inxibelelane ngolwazi malunga nokukhawuleza ukuvunywa kwe-OCA, kwaye sikholelwa ngokuqinisekileyo ukuba yonke idatha ethunyelwe ngoku ihlangabezana neemfuno ze-FDA kwaye ixhasa ngokucacileyo ingozi yenzuzo ye-OCA. Siyazisola ngale CRL. I-FDA iye yandisa ngokuthe ngcembe ubunzima bee-histological endpoints, ngaloo ndlela idala umqobo ophezulu kakhulu ukuba udlule. Ukuthi ga,OCAkuphela kwizigaba ezithathu eziphambili. Le mfuno iphunyeziwe ngexesha lophononongo. Siceba ukudibana ne-FDA ngokukhawuleza ukuze sixoxe ngendlela yokuphumeza isicwangciso sokwamkelwa kolwazi lweCRL kwixesha elizayo. "

Kugqatso lokubamba iyeza lokuqala elidwelisiweyo le-NASH, i-Intercept ibisoloko ikwindawo ephambili kwaye ngoku kuphela kwenkampani efumene idatha yolingo oluqinisekileyo lwasemva kwexesha. Njengonamandla kunye ne-farnesoid X receptor (FXR) agonist,OCAngaphambili ufumene iziphumo ezilungileyo kwisigaba sesi-3 solingo lwezonyango olubizwa ngokuba yiREGENERATE. Idatha ibonise ukuba i-NASH ephakathi ukuya kwi-NASH eyafumana iidosi eziphezulu zeOCAPhakathi kwezigulana, ikota yeempawu ze-fibrosis zesibindi ziphuculwe kakhulu, kwaye imeko ayikhange ibe mandundu.

I-FDA icebise ukuba i-Intercept ingenise ukusebenza kwethutyana kunye nedatha yokhuseleko evela kuphononongo oluqhubekayo lwe-REGENERATE ukuxhasa.Ukubakho kwe-OCAukuvunywa okukhawulezileyo, kwaye yabonisa ukuba iziphumo zexesha elide zophononongo kufuneka ziqhubeke.

NangonaOCAsele ivunyiwe ngaphambili esinye isifo sesibindi esinqabileyo (PBC), intsimi ye-NASH inkulu. Kuqikelelwa ukuba i-NASH ichaphazela izigidi zabantu eUnited States kuphela. Ngaphambili, ibhanki yotyalo-mali ye-JMP Securities yaqikelela ukuba intengiso ephezulu yamachiza e-Intercept inokufikelela kwiibhiliyoni zeedola. Ukuchatshazelwa zezi ndaba ezimbi, ixabiso le-Intercept lehla malunga ne-40% ngoMvulo ukuya kwi-$ 47.25 ngesabelo ngasinye. Amaxabiso esitokhwe kwezinye iinkampani zamayeza eziphuhlise i-NASH nazo ziye zawa. Phakathi kwabo, iMadrigal yehla malunga ne-6%, kwaye iViking, i-Akero kunye neGenFit yehla malunga ne-1%.

Umhlalutyi we-Stifel uDerek Archila ubhale kwingxelo kumxhasi ukuba ukwala kube ngenxa yeziphumo ebezingalindelekanga ezinxulumene nonyango ezenzekaUvavanyo lweklinikhi ye-OCA, oko kukuthi, ezinye izigulane zifunyenweOCA unyango, i-cholesterol eyingozi emzimbeni yanda, nto leyo eyenza ukuba babe nengozi ephezulu ye-cardiovascular risk. Ngenxa yokuba izigulane ezininzi ze-NASH sele zigqithise kakhulu okanye zihlutha isifo seswekile se-2, imiphumo enjalo inokuvusa ukuqapha kwee-arhente ezilawulayo. Ngokweemfuno ze-FDA zedatha yovavanyo olongezelelweyo, i-Intercept inokufuneka ilinde kude kube sisiqingatha sesibini sika-2022 ukutolika ezi datha. Uhlalutyo lwangaphandle lukholelwa ukuba ulibaziseko olude olunjalo lunokuyicima inxenye ye-Intercept yokhokelo oluqokelelweyo lwangaphambili, luvumela abanye abantu abakhuphisana nabo kuquka iMadrigal Pharmaceuticals kunye neViking Therapeutics ukuba babe nethuba lokubamba.