Shares of Eli Lilly and Company (LLY) surged 4.50% to $1,414.93 on Monday, a gain of $60.93, after the company announced positive Phase 3 clinical results for Foundayo, its investigational therapy for obstructive sleep apnea. The stock climbed back from intraday lows near $1,360 as buying pressure strengthened throughout the session. The company reported significant improvements in sleep apnea severity and weight reduction among patients who received the treatment.

Positive Phase 3 Results Across the ATTAIN-OSA Program

Eli Lilly announced the results from its ATTAIN-OSA clinical program, a Phase 3 evaluation of Foundayo, which is also known as orforglipron, an investigational GLP-1 receptor agonist taken as a daily pill. The studies enrolled adults with moderate-to-severe obstructive sleep apnea who were also living with obesity or overweight. Researchers assessed two distinct populations: participants who were already using positive airway pressure (PAP) therapy and those who received no such treatment. That split carries practical weight, because PAP devices — which deliver pressurized air through a mask worn during sleep — are the standard treatment for obstructive sleep apnea, and many patients find them difficult to tolerate over the long term.

After 52 weeks of treatment, Foundayo met the primary endpoint of the studies by significantly reducing the apnea-hypopnea index, a measure that tracks breathing interruptions during sleep and is used to help determine the severity of obstructive sleep apnea. Eli Lilly presented the findings at the American Heart Association Scientific Sessions 2026 and published them in the journal JAMA.

Obstructive sleep apnea affects approximately 936 million adults worldwide, although many cases remain undiagnosed. The condition repeatedly interrupts breathing during sleep and increases risks associated with cardiovascular disease. The positive data arrive as Eli Lilly continues to expand its cardiometabolic portfolio beyond obesity treatments, which include Zepbound, an injectable medication.

Reductions in Sleep Apnea Events and Weight

Among participants who did not use PAP therapy, Foundayo reduced sleep apnea events by 43.8% after 52 weeks. The treatment lowered breathing interruptions by 21.1 events per hour from an average baseline of 50.7 events per hour, a starting level that falls within the severe range of the disease under standard classification. In addition, 47.2% of participants in this group achieved reductions of at least 50% in their apnea-hypopnea index.

Participants using PAP therapy recorded a 27.5% decline in sleep apnea events during treatment. Within that group, 33.7% of participants achieved reductions of at least 50%, while 19.6% reached remission or mild disease. Foundayo also reduced the oxygen-related burden of sleep apnea across both treatment groups.

The treatment delivered average weight reductions of 11.5% among participants who did not use PAP therapy and 11.2% among those who did, exceeding 11% across both patient groups. Participants also recorded improvements in systolic blood pressure and inflammatory markers over the course of the studies. Together, the findings demonstrated benefits across several measures associated with obesity and cardiovascular risk.

FDA Submission Planned by December 2026

Eli Lilly plans to submit Foundayo to the U.S. Food and Drug Administration (FDA) for approval as a treatment for obstructive sleep apnea by December 2026. The company seeks to expand treatment options for adults living with moderate-to-severe disease and excess weight. Regulators must first review the clinical findings before approval can be granted for the additional indication.

Across the studies, the most commonly reported adverse events were gastrointestinal symptoms, including nausea, diarrhea, constipation, indigestion and vomiting. Among participants who did not use PAP therapy, 12.2% discontinued Foundayo because of adverse events, compared with 3.8% receiving placebo. Among PAP users, discontinuation rates reached 6.8% with Foundayo versus 0.6% with placebo.

The positive findings strengthen Eli Lilly's clinical evidence across obesity-related health conditions. The results supported the day's share price advance, reflecting another potential treatment opportunity within the company's cardiometabolic portfolio. The planned FDA submission now represents the next regulatory milestone for Foundayo's sleep apnea indication, with how the agency weighs the Phase 3 data — and where an oral medication ultimately fits alongside device-based care — the key items to watch as the review proceeds.

Source: Blockonomi