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This Month’s Bonus Story

Eli Lilly’s New Drug Data Sets Up a High-Stakes 2026

Submitted by Leo Miller. Originally Published: 12/26/2025. 

Key Points

• Eli Lilly shares continue to climb, with the stock staging a huge recovery in recent months.
• Key data from two of the company’s development drugs supports its outlook.
• The FDA’s decision on orforglipron and clinical data on retatrutide could create large upside or downside moves in LLY shares next year.

Since early August, the world’s most valuable pharmaceutical stock, Eli Lilly and Company (NYSE: LLY), has staged an impressive rebound. After falling 14% on Aug. 7 following disappointing clinical results, shares are now up roughly 71% year-to-date.

Lilly’s weight-loss and diabetes drugs, Zepbound and Mounjaro, are among the most effective treatments currently available and have propelled the company to new heights. Not long ago, Lilly became the first pharmaceutical company to reach a $1 trillion market cap.

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But the products Lilly already sells aren’t the only drivers of the stock. In recent weeks the company released important data on two next-generation weight-loss and diabetes candidates that investors hope will power Lilly’s next phase of growth.

Orforglipron Data Provides Path Toward “Weight Loss Maintenance” Revenue

Orforglipron is Lilly’s oral weight-loss candidate; it has not yet been approved by the Food and Drug Administration (FDA). It differs from the injectable GLP-1 therapies that currently dominate the market.

Although oral GLP-1s tend to be less potent than injectables, Lilly is investing heavily in orforglipron for several reasons. First, pills offer practical advantages for patients, including greater convenience and reduced barriers such as needle phobia, potentially attracting people who are reluctant to use injectables.

Second, pill-based therapies have manufacturing and cost advantages. They are generally cheaper to produce and avoid the additional expense and production time associated with injectable pens, which also can be more susceptible to shortages.

Third, Lilly hopes to market orforglipron as a maintenance therapy for patients who have already achieved substantial weight loss with injectables and want to sustain those results. Lilly’s latest trial results offered encouraging signs for that use case.

In the trial, participants who had lost significant weight on Zepbound or Novo Nordisk’s Wegovy stopped those injectables and took orforglipron for 52 weeks. Former Wegovy users maintained about 95% of their weight loss, while former Zepbound users maintained about 80%.

Those findings suggest a potential path to recurring revenue from a large pool of current and former injectable GLP-1 patients, but the opportunity depends on FDA approval of orforglipron.

Retatrutide Posts Astounding Efficacy, But Tolerability Remains in Question

Lilly is also continuing to advance injectable therapies aimed at delivering even greater weight loss. Its latest trial for the developmental triple-agonist retatrutide produced eye-catching results.

Patients taking retatrutide for 68 weeks lost an average of 28.7% of their body weight. For context, tirzepatide—the active molecule behind Zepbound and Mounjaro—showed about 20.2% weight loss at 72 weeks in a prior study.

The retatrutide data indicate Lilly may be able to develop a treatment that surpasses the efficacy of currently available best-in-class therapies, which would reinforce the company’s leadership in the weight-loss and diabetes markets.

However, the strong efficacy was tempered by tolerability concerns: 18.2% of patients on the highest retatrutide dose discontinued treatment, roughly three times the 6.1% discontinuation rate observed with Zepbound.

Lilly expects to complete seven more retatrutide trials in 2026. Demonstrating similar high levels of weight loss with lower discontinuation rates will be crucial to realizing retatrutide’s full commercial potential.

LLY’s 2026 Catalysts: FDA Decision and Retatrutide Data

These results reinforce why Lilly is a leader in the sector. Looking ahead, FDA approval of orforglipron in 2026 would be a major upside catalyst for the shares, and positive retatrutide readouts would be another significant boost.

That said, failure to obtain orforglipron approval or disappointing retatrutide outcomes would represent meaningful downside risks. Given Lilly’s recent track record, however, the odds may be tilted in its favor.

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