ICPT Tshuag Tumbles Ntawm Qhov Teeb Meem Tshiab Rau Nws Cov Tshuaj NASH

Kev cuam tshuam cov tshuaj lag luam (ICPT) tau hais rau hnub Friday nws qhov kev sim tshuaj kho mob siab yuav ntsib Pawg Saib Xyuas Khoom Noj thiab Tshuaj hauv lub Tsib Hlis, ua rau ICPT cov khoom lag luam poob.

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FDA's Gastrointestinal Drugs Advisory Committee yuav ntsib rau lub Tsib Hlis 19 los tham txog cov txiaj ntsig thiab kev pheej hmoo ntawm Intercept's obeticholic acid raws li kev kho mob rau cov kab mob uas tsis yog-coholic steatohepatitis, lossis NASH. Lub vaj huam sib luag yuav ua cov lus pom zoo tsis sib haum xeeb ntawm cov tshuaj yav tom ntej.

SVB Securities tus kws tshuaj ntsuam Thomas Smith tau hais tias lub rooj sib tham ntawm pawg neeg yuav muab kev pom tseeb ntxiv rau qhov FDA pom obeticholic acid hauv NASH li cas.

"Peb kuj cia siab tias pawg neeg tawm tswv yim no yuav muaj qhov cuam tshuam tseem ceeb rau lwm tus neeg tsim tshuaj NASH, vim nws sawv cev rau thawj qhov kev nkag siab zoo rau FDA cov txheej txheem los tshuaj xyuas NASH cov ntawv thov tshuaj ntau dua," nws hais hauv tsab ntawv tshaj tawm.

On hnub no lub khw lag luam, ICPT cov khoom lag luam poob 13.9% kom kaw ntawm 16.12. Lub caij no, feem ntawm cov tuam txhab biotech gapped txog 3.5%. Lub caij nplooj zeeg dav dua yog vim muaj kev txhawj xeeb tom qab tsoomfwv tswj hwm tau coj tswj ntawm Silicon Valley Bank. Lub txhab nyiaj peev tau tuav txog 44% ntawm Asmeskas kev saib xyuas kev noj qab haus huv thiab thev naus laus zis thawj zaug rau pej xeem muab rau xyoo 2022.

ICPT Tshuag: nthuav dav Ocaliva Kev Siv

Kev cuam tshuam tau ntsib kev sib ntaus sib tua nrog obeticholic acid hauv NASH. Cov tshuaj tau pom zoo raws li kev kho mob rau lwm tus kab mob siab hu ua thawj biliary cholangitis. Nws muag hauv qab lub npe Ocaliva.

Tsis muaj kev pom zoo kho rau NASH. Yuav kom tau txais kev pom zoo, cov tshuaj yuav tsum txhim kho fibrosis - ib daim ntawv ntawm caws pliav ntawm daim siab - los ntawm tsawg kawg ib theem. Fibrosis yog ntsuas nyob rau theem 1-4. Los yog, cov tshuaj yuav tsum txhim kho cov tsos mob ntawm NASH thiab tiv thaiv fibrosis los ntawm kev mob zuj zus.

Thaum Lub Cuaj Hlis 30, Intercept tau hais tias obeticholic acid ua tsis tau qhov txawv ntawm cov neeg mob uas muaj cov kab mob fibrosis phem tshaj plaws, theem 4. Qhov no txhais tau hais tias lawv lub siab muaj qhov caws pliav, hu ua cirrhosis. Feem ntau, cov neeg mob no tsuas muaj sia nyob nrog lub siab hloov pauv. ICPT Tshuag poob 15% hnub ntawd.

Tab sis, thaum Lub Ib Hlis, FDA tau lees txais Intercept daim ntawv thov rau obeticholic acid hauv NASH cov neeg mob uas tsis tshua muaj fibrosis. Ua ntej txiav txim siab seb puas yuav pom zoo lossis tsis lees txais daim ntawv thov nyob rau lub Rau Hli, FDA yuav tuav lub rooj sib tham pawg neeg tawm tswv yim. SVB's Smith cia siab tias lub rooj sib tham yuav muaj kev sib tw rau Intercept.

Intercept tab tom ntsib Madrigal Pharmaceuticals (MDGL) hauv lub khw no. Madrigal tau qhab nia yeej nrog lub zog 3 qhov tshwm sim hauv NASH thaum Lub Kaum Ob Hlis. Raws li Madrigal shares tripled, ICPT Tshuag poob 23.5%.

Lub rooj sib tham yuav muab NASH kev pom dav dav

Lub rooj sib tham FDA yuav muab qee qhov kev pom thoob plaws NASH qhov chaw txhim kho, Smith tau hais.

"Peb ntseeg tias pawg neeg tawm tswv yim yuav ua lub rooj sib tham los muab qhov xav tau ntau yam meej rau yuav ua li cas FDA pom ob qho tib si obeticholic acid txaus ntshai / txiaj ntsig hauv NASH, nrog rau kev nkag siab dav dua rau cov txheej txheem tshuaj xyuas cov lus qhia no, nrog rau qhov cuam tshuam tseem ceeb rau lwm yam. NASH players dhau Intercept, "nws hais.

Nws khaws nws lub lag luam ua qhov ntsuas ntawm ICPT Tshuag. Ntawm xov xwm hnub Friday, shares poob qis dua lawv 50-hnub txav nruab nrab, MarketSmith.com qhia. Intercept stock muaj zog Ntsuam Xyuas Lub Zog Muaj Zog ntawm 93, txawm li cas los xij. Qhov no tso cov khoom lag luam rau saum 7% ntawm tag nrho cov khoom lag luam thaum nws los txog rau 12 lub hlis ua haujlwm, raws li IB Digital.

Ua raws li Allison Gatlin ntawm Twitter ntawm @IBD_AGatlin.

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