Year Of NASH Upheaval Means Incremental Data At AASLD
Firms Are Retrenching, But There Are Signs Of Progress
With still no approved therapy for non-alcoholic steatohepatitis, Intercept, Madrigal, Inventiva and others used the liver meeting to build the cases for their NASH candidates.
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While plans to obtain accelerated approval of lanifibranor remain unchanged, Inventiva now plans to conduct the confirmatory Phase III in cirrhotic patients, meaning a shorter trial duration and possibly broader label.
Looking ahead to lengthy, expensive Phase III NASH studies, Akero looks to tap public markets for $200m. Analysts call EFX’s Phase IIb data potentially best-in-class.
Public Company Edition: Applied Molecular Transport, Scholar Rock, Agios and others join many of their peers in revising their strategies and downsizing their teams. Also, Zentalis grossed $200m from a follow-on offering and OKYO Pharma went public in the year’s smallest biopharma IPO in the US.