Eli Lilly plans to submit a Biologics License Application for retatrutide—a triple GIP/GLP-1/glucagon receptor agonist—only in Q1 2027 after completing its chemistry, manufacturing, and controls package, following positive Phase 3 TRIUMPH trial readouts showing up to 22.6% weight loss at 80 weeks. With roughly three months remaining in 2026, standard FDA review timelines of 10–12 months (or six months under priority review) make approval this calendar year highly improbable. Trader consensus at 96.5% reflects these regulatory and manufacturing prerequisites rather than efficacy concerns. A realistic shift could occur only through an unanticipated early submission and expedited review, though no such acceleration has been signaled.