89bio Announces U.S. FDA Has Granted Breakthrough Therapy Designation For Pegozafermin In Nonalcoholic Steatohepatitis
Portfolio Pulse from Benzinga Newsdesk
89bio, Inc. (NASDAQ:ETNB) has announced that the U.S. FDA has granted Breakthrough Therapy Designation (BTD) to pegozafermin, a treatment for nonalcoholic steatohepatitis (NASH). The designation is supported by positive data from the ENLIVEN Phase 2b trial of pegozafermin. The company plans to discuss the NASH Phase 3 program with regulatory agencies in the fourth quarter of 2023.
September 21, 2023 | 12:10 pm
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POSITIVE IMPACT
89bio's pegozafermin has been granted Breakthrough Therapy Designation by the FDA, which could expedite the development and review of the product. This is likely to positively impact the company's stock in the short term.
The FDA's Breakthrough Therapy Designation is a significant milestone for 89bio and its product pegozafermin. This designation is likely to expedite the development and review of the product, which could lead to earlier market entry and revenue generation. This positive news is likely to boost investor confidence and positively impact the company's stock in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100