Regulatory Progress and Production Scale-Up Might Change the Case for Investing in 89bio (ETNB)

• 89bio, Inc. recently announced its second quarter 2025 earnings results, reporting a net loss of US$111.5 million and providing updates on its late-stage clinical programs for pegozafermin targeting MASH and severe hypertriglyceridemia.
• An important development is the company’s alignment with the FDA and EMA for accelerated approval pathways and ongoing progress in scaling up commercial production capacity.
• We’ll explore how updates on pegozafermin’s clinical trial timelines and regulatory strategy shape 89bio’s current investment narrative.

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What Is 89bio's Investment Narrative?

To see value in 89bio right now, you have to believe in the promise of pegozafermin and the company’s ability to secure timely regulatory approvals, scale commercial operations, and eventually break into the market for treating metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia. The latest earnings showed expanding quarterly losses, a net loss of US$111.5 million, reflecting heavier investment into late-stage clinical trials and production capacity. The key short-term catalyst remains progress and clarity on the Phase 3 trial timelines and interim regulatory feedback, which the company recently advanced by signaling FDA and EMA alignment on accelerated approval pathways. This progress is potentially reassuring but doesn’t materially reduce the existing risks: clinical trial outcomes, a long runway to any potential revenue, and ongoing dilution as seen in the recent past. Most important: The company’s path to commercialization is as urgent as ever, with little margin for clinical setbacks or regulatory delays. Unlike regulatory milestones, clinical results still carry significant risk for early investors.

89bio's shares have been on the rise but are still potentially undervalued. Find out how large the opportunity might be.

Exploring Other Perspectives

The Simply Wall St Community includes two fair value estimates ranging from US$29.36 to US$177.08 per share. While some see extreme valuation upside, these diverging views underline how much rides on clinical and regulatory milestones investors are still waiting for. Explore the spread in community opinions and how changing timelines can shift sentiment.

Explore 2 other fair value estimates on 89bio - why the stock might be worth just $29.36!

Build Your Own 89bio Narrative

Disagree with this assessment? Create your own narrative in under 3 minutes - extraordinary investment returns rarely come from following the herd.

• A great starting point for your 89bio research is our analysis highlighting 1 key reward and 3 important warning signs that could impact your investment decision.
• Our free 89bio research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate 89bio's overall financial health at a glance.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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