NASH Updates: Intercept Moves Toward Re-Filing, Madrigal De-Risks Phase III
AASLD Briefing: While working on new biopsy reviews to address CRL, Intercept also might consider filing for approval in cirrhotic patients if REVERSE study succeeds. Plus other updates on NASH programs.
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89bio’s Phase IIb Data Heighten Competition Within NASH FGF21 Analog Class
89bio’s pegozafermin met co-primary endpoints of fibrosis reduction and NASH resolution in Phase IIb; the company said its methodology yielded lower placebo responses than in Akero’s Phase IIb study.
Imminent Madrigal, Viking Trial Readouts Will Shape NASH R&D Expectations
While neither company reported new data from their ongoing trials at AASLD, the firm’s competing THRβ agonists are viewed as leading lights in the non-alcoholic steatohepatitis competition.
Akero’s Phase II Success Could Augur Brighter Days For NASH R&D
With Akero’s FGF21 analog showing ability to reduce fibrosis and resolve non-alcoholic steatohepatitis, some analysts think classmate BIO89-100 could yield a better overall profile. NASH data are starting to pour in.