Key insights
- Eli Lilly's Foundayo met its cardiovascular safety endpoint in a Phase 3 diabetes trial, showing a reduction in cardiovascular events compared to insulin glargine. The drug also demonstrated a significant reduction in all-cause mortality in a pre-planned analysis. The positive trial results reinforce Lilly's diabetes portfolio and may positively influence investor sentiment, given the company's strong financial health and growth prospects.
INDIANAPOLIS - Eli Lilly and Company (NYSE:LLY) announced Thursday that its oral diabetes drug Foundayo met the primary cardiovascular safety endpoint in the Phase 3 ACHIEVE-4 trial, according to a press release statement. The pharmaceutical giant, with a market capitalization of $809.84 billion, continues to strengthen its diabetes portfolio amid impressive revenue growth of 44.7% over the last twelve months.
The trial enrolled more than 2,700 participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk across 15 countries. Foundayo demonstrated non-inferior risk of major adverse cardiovascular events compared to insulin glargine, meeting prespecified criteria with a hazard ratio of 0.84 and a 95% confidence interval of 0.59 to 1.20.
The study showed Foundayo reduced the risk of cardiovascular death, heart attack, stroke, or hospitalization for unstable chest pain by 16% compared to insulin glargine. In a pre-planned analysis not controlled for multiplicity, all-cause death risk was 57% lower with Foundayo versus insulin glargine, with a hazard ratio of 0.43.According to InvestingPro analysis, Lilly shares appear undervalued at current levels, with the stock earning a "GREAT" financial health score. The company maintains an impressive gross profit margin of 83% while trading at a PEG ratio of 0.41, suggesting attractive valuation relative to growth prospects. For deeper insights, investors can access comprehensive Pro Research Reports covering Lilly and 1,400+ other US equities.
At 52 weeks, participants taking Foundayo experienced a 1.6% reduction in A1C from a baseline of 8.22%, compared to 1.0% for insulin glargine. Body weight decreased 8.8% with Foundayo versus a 1.7% increase with insulin glargine from a baseline of 90.9 kg.
The most common adverse events for Foundayo were nausea, vomiting, diarrhea, decreased appetite, and constipation. During the 52-week minimum treatment period, 10.6% of patients discontinued treatment due to adverse events. The company stated analyses confirmed no hepatic safety signal.
Lilly plans to submit Foundayo for type 2 diabetes treatment to the U.S. Food and Drug Administration by the end of the second quarter. Foundayo is currently FDA-approved for chronic weight management in adults with obesity or overweight with weight-related medical problems. The company has maintained dividend payments for 56 consecutive years, underscoring its financial stability as a prominent player in the pharmaceuticals industry.
The once-daily oral medication can be taken without food or water restrictions. ACHIEVE-4 represents the largest and longest study of Foundayo in type 2 diabetes to date.
In other recent news, Eli Lilly has seen significant developments across various fronts. The company announced that its Phase 3 BRUIN CLL-322 trial met its primary endpoint, demonstrating improved progression-free survival for patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma using Jaypirca. This trial enrolled 639 patients and showed promising results for the combination therapy of Jaypirca, venetoclax, and rituximab. Additionally, Eli Lilly’s new oral GLP-1 medication, Foundayo, has been added to Weight Watchers’ Med+ program, offering an injection-free option for adults with obesity or weight-related medical issues. Analyst firms have also weighed in on Eli Lilly’s prospects. BMO Capital reiterated an Outperform rating with a $1,300 price target, citing manageable post-marketing study requirements for Foundayo. Leerink Partners echoed this sentiment with a $1,296 price target following positive trial data for Jaypirca. Furthermore, RBC Capital maintained an Outperform rating and a $1,250 price target, expecting strong sales for Zepbound and Mounjaro in the future. These recent developments highlight Eli Lilly’s ongoing efforts in advancing its treatment options and maintaining a strong market position.
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