Eli Lilly’s planned Biologics License Application filing for retatrutide in the first quarter of 2027 drives the market-implied 98.9% probability against 2026 FDA approval. Multiple Phase 3 TRIUMPH trials have delivered strong results, including mean weight reductions of 20–25% at the 12 mg dose over 80 weeks and A1C improvements up to 1.6 percentage points in type 2 diabetes participants, yet the company has not submitted any marketing application and is still finalizing the chemistry, manufacturing, and controls package. Standard FDA review timelines of 10–12 months after filing place any potential approval in late 2027 or later. A realistic shift could occur only if Lilly submits far earlier than announced or the agency grants unusually rapid priority review, both of which remain unlikely based on current regulatory status.