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 izibonelelo 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 ukuntsonkotha kokuphela kwe-histological, ngaloo ndlela idala umqobo ophezulu kakhulu ukuba udlule.Ukuthi ga,OCAkuphela kwizigaba ezithathu eziphambili.Le mfuno ifezekisiwe 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.Njengomntu onamandla 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 zesibindi sezigulana ziye zaphuculwa kakhulu, kwaye imeko ayizange ibe mandundu.

I-FDA icebise ukuba i-Intercept ingenise ukusebenza kwethutyana okongeziweyo kunye nedatha yokhuseleko evela kuphononongo oluqhubekayo lwe-REGENERATE ukuxhasa.Okunokwenzeka 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 yangaphambili eqokelelweyo, ivumela abanye abantu abakhuphisana nabo kuquka iMadrigal Pharmaceuticals kunye neViking Therapeutics ukuba babe nethuba lokubamba.