Eli Lilly has completed five positive Phase 3 trials for retatrutide, its investigational GIP/GLP-1/glucagon triple agonist, demonstrating up to 22.6% mean weight loss at 80 weeks in populations with obesity, type 2 diabetes, and cardiovascular disease. However, the company has stated it will not submit the Biologics License Application until Q1 2027 once the chemistry, manufacturing, and controls package is finalized. With no filing yet and standard FDA review timelines of 10–12 months or longer after acceptance, approval remains impossible in 2026. Trader consensus at 96.5% for “No” reflects this fixed regulatory sequence and the absence of any accelerated pathway or early submission signals. Unexpected early filing or priority review designation could theoretically compress timelines, though current data show no such developments.