Crispr Therapeutics shares tumble after significant earnings miss
Investing.com -- Eli Lilly and Company (NYSE:LLY) stock fell on Thursday morning after the pharmaceutical giant’s diabetes drug Mounjaro failed to demonstrate superiority over its older GLP-1 drug Trulicity in a cardiovascular outcomes trial.
Lilly’s shares declined as much as 4.5% before paring the drop to 2.25% following the release of topline results from the SURPASS-CVOT trial, which compared the two incretin therapies in adults with type 2 diabetes and established atherosclerotic cardiovascular disease.
While Mounjaro met its primary objective of non-inferiority with an 8% lower rate of major adverse cardiovascular events (MACE-3) compared to Trulicity, the results fell short of proving superiority. The trial showed a hazard ratio of 0.92 with a 95.3% confidence interval of 0.83 to 1.01, missing the threshold for statistical superiority.
The study did show some positive secondary outcomes, including a 16% lower rate of all-cause mortality for Mounjaro versus Trulicity. Mounjaro also demonstrated greater improvements in A1C, weight reduction, and kidney function measures. However, these secondary endpoints were not controlled for multiplicity-adjusted type 1 error.
Bloomberg Intelligence analyst Michael Shah called outcomes of the trial positive but underwhelming.
"Eli Lilly’s Mounjaro met the primary endpoint in the SURPASS-CVOT trial, demonstrating a non-inferior rate of major adverse cardiovascular events vs. Trulicity. Yet this is undermined by the fact that the trial also tested for superiority, but that was not achieved (or at least not disclosed in the initial release). The commercial implications could be limited, as prescribers generally view Mounjaro as a more effective GLP-1 than Trulicity."
Lilly plans to present detailed results at the European Association for the Study of Diabetes Annual Meeting in September and submit the data to global regulatory authorities by year-end.