NgoJuni 29,I-Intercept Pharmaceuticals imenyezelweukuthi ithole isicelo somuthi esisha esiphelele esivela ku-US FDA mayelana ne-FXR agonist obeticholic acid (OCA) yayo ye-fibrosis ebangelwa i-non-alcoholic steatohepatitis (NASH) Response letter (CRL). I-FDA isho ku-CRL ukuthi ngokusekelwe kudatha ebuyekeziwe kuze kube manje, ikholelwa ukuthi izinzuzo ezilindelekile zomuthi ngokusekelwe kwezinye iziphetho zesilingo se-histopathology zisangaqiniseki, futhi izinzuzo zokwelashwa azeqi izingozi ezingaba khona, ngakho azenzi. ukusekela ukugunyazwa okusheshisiwe kwe-OCA yokwelashwa kwe-NASH Iziguli ezibangela i-liver fibrosis.

UMark Pruzanski, uMongameli kanye ne-CEO ye-Intercept, iphawule ngemiphumela: “Phakathi nenqubo yokubuyekeza, i-FDA ayikaze ikhulume ngolwazi lokusheshisa ukugunyazwa kwe-OCA, futhi sikholelwa ngokuqinile ukuthi yonke idatha ethunyelwe kuze kube manje ihlangabezana nezimfuneko ze-FDA futhi Isekela ngokucacile ingcuphe yenzuzo enhle ye-OCA. Siyazisola ngale CRL. I-FDA inyuse kancane kancane ubunkimbinkimbi bezindawo zokugcina ze-histological, ngaleyo ndlela idale umgoqo ophezulu kakhulu ukuthi udlule. Kuze kube manje,OCAisezigabeni ezintathu ezibalulekile kuphela. Lesi sidingo sihlangatshezwe ngesikhathi socwaningo. Sihlela ukuhlangana ne-FDA ngokushesha okukhulu ukuze sixoxe ngokuthi singaludlulisa kanjani uhlelo lokugunyaza ngolwazi lwe-CRL esikhathini esizayo.”

Emncintiswaneni wokuthatha umuthi wokuqala esohlwini lwe-NASH, i-Intercept ibihlezi isendaweni ehamba phambili futhi okwamanje iyona kuphela inkampani ethole idatha yesilingo sesigaba sakamuva esihle. Njenge-agonist enamandla futhi ethize ye-farnesoid X receptor (FXR),OCAngaphambilini uthole imiphumela emihle esivivinyweni somtholampilo sesigaba sesi-3 esibizwa ngokuthi REGENERATE. Idatha ibonise ukuthi i-NASH emaphakathi ukuya kokuqina ethole imithamo ephezulu yeOCAPhakathi kweziguli, ingxenye eyodwa kwezine yezimpawu ze-liver fibrosis yeziguli isithuthuke kakhulu, futhi isimo asikabi sibi.

I-FDA income ukuthi i-Intercept ilethe ukusebenza ngempumelelo kwesikhashana okwengeziwe kanye nedatha yokuphepha evela ocwaningweni oluqhubekayo lwe-REGENERATE ukuze isekele.Amandla we-OCAyasheshisa ukugunyazwa, futhi yaveza ukuthi imiphumela yesikhathi eside yocwaningo kufanele iqhubeke.

NakubaOCAiye yavunyelwa ngaphambilini ngesinye isifo sesibindi esingavamile (PBC), insimu ye-NASH inkulu. Kulinganiselwa ukuthi i-NASH ithinta izigidi zabantu e-United States kuphela. Ngaphambilini, ibhange lokutshalwa kwezimali i-JMP Securities lalilinganisela ukuthi inani eliphakeme lokuthengiswa kwezidakamizwa ze-Intercept lingafinyelela izigidigidi zamadola. Ethintwe yilezi zindaba ezimbi, intengo yesitoko se-Intercept yehle cishe ngo-40% ngoMsombuluko yaya ku-$47.25 ngesheya ngalinye. Izintengo zamasheya zezinye izinkampani ezenza imithi nazo ezithuthukise i-NASH nazo zehlile. Phakathi kwazo, iMadrigal yehle cishe ngo-6%, kwathi amaViking, Akero kanye neGenFit ehle cishe ngo-1%.

Umhlaziyi we-Stifel uDerek Archila ubhalele iklayenti embikweni ukuthi ukwenqaba kwakungenxa yemiphumela engemihle ehlobene nokwelashwa eyenzeke ngo.Ukuhlolwa komtholampilo kwe-OCA, okungukuthi, ezinye iziguli zatholaUkwelashwa kwe-OCA, i-cholesterol eyingozi emzimbeni yanda, okubuye Kubenze babe nengozi enkulu yengozi yenhliziyo. Njengoba kunikezwe ukuthi iziguli eziningi ze-NASH sezivele zikhuluphele ngokweqile noma zihlushwa isifo sikashukela sohlobo 2, imiphumela enjalo engemihle ingase ivuse ukuqapha kwama-ejensi alawulayo. Ngokwezidingo ze-FDA zedatha yokuhlola eyengeziwe, i-Intercept kungase kudingeke ilinde kuze kube okungenani ingxenye yesibili ka-2022 ukuze ihumushe le datha. Ukuhlaziya kwangaphandle kukholelwa ukuthi ukubambezeleka okude kangako kungase kuqede ingxenye yokuhola enqwabelene yangaphambilini ye-Intercept, kuvumele abanye abaqhudelana nabo okuhlanganisa iMadrigal Pharmaceuticals kanye neViking Therapeutics ukuthi babe nethuba lokuyifica.