Liminal BioSciences Inc. LMNL

Tic Toc

[skyhigh123]

Gilead And Selonsertib In NASH Fibrosis And Compensated Cirrhosis: The FDA Guidelines For Conditional Approval

Jan. 27, 2019 12:41 PM •GILD

Summary

• Selonsertib, a apoptosis signal-regulating kinase-1 inhibitor, is a dual anti-apoptotic and anti-inflammatory Phase 3 anti-NASH drug candidate.
• In Q1/2019 and Q2/2019, Gilead is expected to announce the top-line Phase 3 interim data readouts for selonsertib in the NASH compensated cirrhosis and NASH fibrosis trials, respectively.
• To gain conditional FDA approval, selonsertib must therapeutically and histologically achieve its primary clinical outcome in the interim data readout.
• I summarize the FDA guideline.