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89bio to Present 48-Week Data from ENLIVEN Phase 2b Pegozafermin Trial in Metabolic Dysfunction-Associated Steatohepatitis (MASH) at EASL International Liver Congress

89bio to Present 48-Week Data from ENLIVEN Phase 2b Pegozafermin Trial in Metabolic Dysfunction-Associated Steatohepatitis (MASH) at EASL International Liver Congress
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United statesSan franciscoUniversity of california san diegoHank mansbachAnnie changArunj sanyalSheryl seapyRohit loombaLifesci advisorsDivision of gastroenterologyInternational liver congressVirginia commonwealth universityExchange commissionDrug administrationWeek dataPegozafermin trial

89bio s MASH Drug Begins Phase III, Aiming to Stand Out in Growing Field

89bio s MASH Drug Begins Phase III, Aiming to Stand Out in Growing Field
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United statesHank mansbachEli lillyBoston pharmaceuticalsData monitoring committeeMadrigal pharmaceuticalsGalmed pharmaceuticalsNovo nordiskGalectin therapeuticsSuspected unexpected serious adverse reactionBoston pharmaceuticalPark cityAkero therapeuticPrescription drug user fee actNew england journalExtension phase

Pegozafermin Enters Phase 3 Clinical Trial Program for MASH, Fibrosis

The phase 3 ENLIGHTEN program will consist of 2 phase 3 trials evaluating the safety and efficacy of pegozafermin in patients with MASH.

Hank mansbachRohit loombaUc san diego health rohit loombaDrug administrationDiego healthCalifornia san diego schoolBreakthrough therapy designationChief medical officerInitiates phaseFibrosis trialGranted breakthrough therapy designationNonalcoholic steatohepatitisShows sustained benefit

89bio Reaches Alignment with the FDA and EMA on Phase 3 Program for Pegozafermin in Nonalcoholic Steatohepatitis (NASH); Program Initiation Planned in the First Half of 2024

Alignment reached on key elements of the NASH development strategy, including accelerated approval pathway for both F4 and F2-F3 NASH patients using histology Outcomes trial in F4.

United statesSan franciscoSheryl seapyAnnie changHank mansbachUs food drug administrationDrug administrationExchange commissionLifesci advisorsChief medical officerBreakthrough therapyAnnual reportSafe harborPrivate securities litigation reform actSci advisors

89bio (ETNB) Reaches Alignment with the FDA and EMA on Phase 3 Program for Pegozafermin in Nonalcoholic Steatohepatitis

89bio (ETNB) Reaches Alignment with the FDA and EMA on Phase 3 Program for Pegozafermin in Nonalcoholic Steatohepatitis
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United statesHank mansbachUs food drug administrationDrug administrationChief medical officerBreakthrough therapy