• On October 27, 2025, Eli Lilly announced that the U.S. FDA approved a new, once-monthly single-injection maintenance regimen of Omvoh (mirikizumab) for adults with moderately to severely active ulcerative colitis, simplifying patient treatment and supporting global immunology portfolio expansion.

• This regulatory milestone coincides with new Phase 3 clinical data showing Omvoh’s efficacy in improving key patient symptoms, enhancing both product differentiation and potential uptake in a competitive market.

• We’ll explore how the FDA approval of Omvoh’s simplified dosing regimen could reinforce Eli Lilly’s growth thesis and market leadership.

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To own Eli Lilly shares, investors need to believe in the company’s continued dominance in obesity and diabetes medicines, the productivity of its clinical pipeline, and robust execution in global expansion. The latest FDA approval for Omvoh’s simplified monthly dosing for ulcerative colitis adds a differentiated product to Lilly’s immunology portfolio, but it does not materially change the main near-term catalyst, sustained sales momentum in blockbuster drugs like Mounjaro and Zepbound. The largest risk remains regulatory or payer-driven drug pricing pressures, which could threaten earnings growth if reform accelerates or spreads internationally.

One of the most interesting recent announcements is Lilly’s partnership with NVIDIA to build a powerful AI supercomputer for drug discovery. While this does not directly affect the immunology portfolio, advanced computing is expected to strengthen Lilly’s pipeline productivity, potentially safeguarding against pipeline concentration risk if challenges emerge for core drugs like Zepbound or Mounjaro. However, concerns remain about…

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Eli Lilly is projected to reach $89.1 billion in revenue and $34.2 billion in earnings by 2028. This outlook is based on an annual revenue growth rate of 18.7% and an earnings increase of $20.4 billion from the current level of $13.8 billion.

Uncover how Eli Lilly’s forecasts yield a $891.62 fair value, a 9% upside to its current price.

Thirty individual members of the Simply Wall St Community estimate Eli Lilly’s fair value between US$650 to US$1,189. Some views reflect caution as pricing reform risk may significantly affect long-term profitability and margin expansion.

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