89bio Reaches Alignment with the FDA and EMA on Phase III Program for Pegozafermin in Nonalcoholic Steatohepatitis (NASH); Program Initiation Planned in the First Half of 2024

89bio, Inc. announced a successful end-of-phase II Meeting with the US FDA, supporting the advancement of pegozafermin into Phase III in NASH. The program will include two Phase 3 trials evaluating patients with NASH: ENLIGHTEN-Cirrhosis will enroll patients with compensated cirrhosis and ENLIGHTEN-Fibrosis will enroll patients with fibrosis stage F2-F3.