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

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 put on a stellar performance. After tanking 14% on Aug. 7 due to poor clinical trial results, shares have gained a whopping 71% year-to-date.

Lilly’s weight loss and diabetes drugs, Zepbound and Mounjaro, are the most efficacious of their kind currently available to patients. These therapies have allowed Lilly to take the pharmaceutical world by storm, with the stock reaching unprecedented milestones. Not too long ago, Lilly became the first pharmaceutical company to hit a $1 trillion market cap.

Despite its already incredible success, the drugs Lilly currently sells are not the only ones driving its stock price. Over the past few weeks, Lilly has released important data on two of its next-generation weight loss and diabetes drugs. The company, as well as many investors, hopes that these therapies can help drive Lilly’s next leg of achievement.

Orforglipron Data Provides Path Toward “Weight Loss Maintenance” Revenue

Orforglipron is Lilly’s weight loss drug pill, which the Food and Drug Administration (FDA) has not yet approved. It differs from the therapies that dominate the market today, which doctors administer through injectables.

Although oral GLP-1s are significantly less effective than injectable GLP-1s, Lilly is putting a lot of effort into developing orforglipron for several key reasons. First off, pills can offer several practical benefits to patients over injectables. This includes increased convenience and eliminating mental barriers like needle phobia. Lilly hopes to attract a new group of patients for whom these are important issues.

Second, pill-based therapies offer key manufacturing benefits. They are significantly cheaper to make, as the injectable pens used to administer Zepbound and Mounjaro add a layer of costs. Pills can also reduce the risk of shortages, as injectables take significantly longer to produce.

Third, Lilly hopes to sell orforglipron to patients who have already lost a lot of weight using injectables and are looking to maintain their weight loss. Lilly’s latest trial results provided encouraging signs on this front.

The company gathered patients who lost a significant amount of weight using Zepbound or Wegovy, made by Novo Nordisk A/S NYSE: NVO. These patients stopped using those medications and switched to orforglipron for 52 weeks. Lilly found that past Wegovy patients maintained 95% of their weight loss, and past Zepbound patients maintained 80% of their weight loss.

This data supports the possibility of Lilly generating recurring revenue through a cohort of patients seeking support in maintaining their weight loss. With there being so many current and past injectable GLP-1 patients, this could be a very large opportunity. However, the FDA still needs to approve orforglipron for this possibility to become a reality.

Retatrutide Posts Astounding Efficacy, But Tolerability Remains in Question

Despite its orforglipron efforts, Lilly is not forgetting about injectables in the least bit. It is continually trying to develop medicines that can allow patients to lose more weight. On this front, its latest trial for the developmental drug retatrutide impressed.

Lilly found that patients taking retatrutide for 68 weeks lost an average of 28.7% of their body weight. For reference, tirzepatide, the clinical name for Zepbound and Mounjaro, led patients to lose 20.2% of their weight at 72 weeks.

This retatrutide data shows that Lilly may be able to develop a drug that is even better than the most effective treatments currently available. This would go a long way in supporting the continuation of Lilly’s dominance in the weight loss and diabetes drug market.

However, retatrutide's positive weight loss numbers were offset by its elevated discontinuation rate. Overall, 18.2% of patients taking the highest dose of retatrutide discontinued the treatment, three times higher than the 6.1% discontinuation rate seen among Zepbound patients.

Lilly still has seven more retatrutide trials that it expects to complete in 2026. Generating data that shows extremely high weight loss combined with lower discontinuation rates will be key to unlocking retatrutide’s full potential.

LLY’s 2026 Catalysts: FDA Decision and Retatrutide Data

Overall, Lilly continues to show why it is the top dog in pharma with these results. Looking forward, the approval of orforglipron in 2026 is a key potential upside catalyst for Lilly shares. Positive retatrutide readouts are another big potential upside catalyst.

Still, investors should recognize that failure to gain orforglipron approval and negative retatrutide readouts would be large downside catalysts. However, given Lilly’s demonstrated success in the past, the odds look tilted in its favor.