89bio Reaches Alignment with the FDA And EMA on Phase 3 Program for Pegozafermin in Nonalcoholic Steatohepatitis, Program Initiation Planned in the First Half of 2024
Portfolio Pulse from Benzinga Newsdesk
89bio has announced alignment with the FDA and EMA on a Phase 3 program for Pegozafermin, a treatment for Nonalcoholic Steatohepatitis (NASH). The program is set to begin in the first half of 2024.

December 04, 2023 | 12:05 pm
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89bio, trading as ETNB, has aligned with regulatory agencies for a Phase 3 trial of Pegozafermin, potentially boosting investor confidence.
The alignment with the FDA and EMA is a significant regulatory milestone for 89bio and its drug Pegozafermin. This positive development is likely to be viewed favorably by investors, as it suggests a clear regulatory path forward and may increase the likelihood of the drug reaching the market. The initiation of the Phase 3 program is a critical step in drug development, and successful trials could lead to eventual approval and commercialization, which would have a substantial impact on the company's revenues and growth prospects.
CONFIDENCE 90
IMPORTANCE 85
RELEVANCE 100