FDA OKs Once-Monthly Omvoh Injection Could Be a Game Changer for Eli Lilly (LLY)

• Eli Lilly and Company recently received U.S. FDA approval for a once-monthly, single-injection maintenance regimen of Omvoh (mirikizumab) for adults with moderately to severely active ulcerative colitis, with the simplified dosing expected to become available in early 2026.
• This regulatory milestone is significant as it may enhance treatment adherence and convenience, while further strengthening Eli Lilly’s immunology portfolio and competitive positioning in inflammatory bowel disease.
• With this new single-injection option improving quality of life for ulcerative colitis patients, we'll explore its influence on Eli Lilly’s broader investment narrative.

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Eli Lilly Investment Narrative Recap

Owning Eli Lilly often comes down to confidence in its ability to deliver consistent revenue and earnings growth through innovation in diabetes, obesity, and immunology while managing intense pricing and market access pressures. The recent FDA approval for once-monthly Omvoh dosing may support the company’s immunology ambitions but is unlikely to move the needle on the short-term narrative, which remains shaped by performance and access for blockbuster incretin drugs and any shifts in pricing regulation or reimbursement risk in the US and Europe.

Among recent events, the board’s declaration of a US$1.50 per share fourth-quarter dividend reflects confidence in the company’s cash flow and profit outlook, underscoring the strength of its operational performance as new products like Omvoh come to market. This consistency in capital return may reassure investors focused on sustainability in the face of competitive and regulatory headwinds. Yet, it is important for investors to recognize...

Read the full narrative on Eli Lilly (it's free!)

Eli Lilly's outlook anticipates $89.1 billion in revenue and $34.2 billion in earnings by 2028. This is based on an expected 18.7% annual revenue growth and a $20.4 billion increase in earnings from the current $13.8 billion.

Uncover how Eli Lilly's forecasts yield a $891.62 fair value, a 8% upside to its current price.

Exploring Other Perspectives

Simply Wall St Community members provided 30 fair value estimates for Eli Lilly, with targets spanning from US$650 to US$1,189 per share. Their views reflect genuine debate on future earnings and potential risks around drug pricing and reimbursement, inviting you to explore several differing viewpoints for a broader picture.

Explore 30 other fair value estimates on Eli Lilly - why the stock might be worth 21% less than the current price!

Build Your Own Eli Lilly Narrative

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

• A great starting point for your Eli Lilly research is our analysis highlighting 3 key rewards and 2 important warning signs that could impact your investment decision.
• Our free Eli Lilly research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Eli Lilly'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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