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89bio, Inc.

https://www.89bio.com

Latest From 89bio, Inc.

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.

Business Strategies Clinical Trials

Finance Watch: Public Market Doldrums Have Not Sunk Private Company Funding Yet

ARCH closed a $3bn VC fund to end the month of June while in the same week six public biopharma firms said they are cutting jobs. Even so, some publicly traded companies have been able to launch sizeable offerings, including a $450m note sale by Cytokinetics and Xenon’s $250m follow-on. 

Financing Business Strategies

Intercept Plans To Refile OCA For NASH At US FDA With Consensus Reads Of Patient Biopsies

Additional patients and more long-term data could also help make case for obeticholic acid. Intercept hopes to complete its review of the pivotal REGENERATE trial during H1 2022.

Drug Review Drug Approval Standards

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.

Clinical Trials Drug Approval Standards
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