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.
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What Does The Negative FDA Review For Intercept’s OCA Hold For Other NASH Drugs?
An FDA advisory committee’s “no” votes for Intercept’s obeticholic acid in non-alcoholic steatohepatitis could augur tough reviews for other NASH candidates. But some could enjoy smoother regulatory tides than OCA.
Finance Watch: LSP Dementia Fund Closes With €260m For Neurodegenerative Diseases
EQT Life Sciences completed the final close of its inaugural LSP Dementia Fund, far surpassing an initial $100m fundraising goal. Also, Resilience received a $410m commitment from the Department of Defense to fund biomanufacturing and Viking cashed in on Phase I obesity data with a $250m offering.
Intercept, Madrigal Get Ready For NASH Commercialization
With a 22 June US FDA action date for obeticholic acid in non-alcoholic steatohepatitis, Intercept is thinking ahead to launch plans. Madrigal said it plans a Q2 filing for its NASH drug and hopes to find an ex-US commercial partner.