Eli Lilly has not submitted a Biologics License Application for retatrutide, its investigational triple agonist targeting GIP, GLP-1, and glucagon receptors. The company plans to file in the first quarter of 2027 once its Chemistry, Manufacturing, and Controls package is complete, following positive Phase 3 TRIUMPH trial results showing substantial weight loss (up to 22.6% at 80 weeks) and A1C reductions. With no filing yet and standard FDA review timelines exceeding the remaining weeks of 2026, trader consensus heavily favors no approval this year. Unexpected acceleration of manufacturing data or a rare expedited pathway could theoretically shift outcomes, though current regulatory status makes this improbable.