Eli Lilly has not yet submitted a Biologics License Application for the investigational triple agonist retatrutide, with the company confirming plans to file only in the first quarter of 2027 after completing manufacturing and quality data. Positive Phase 3 TRIUMPH trial results, including up to 25% mean weight loss and cardiometabolic benefits at 80 weeks, strengthen the clinical package but do not alter the regulatory timeline. Standard FDA review requires 10–12 months after filing, placing any potential approval decision in late 2027 or 2028. Trader consensus at 97.4% “No” reflects this fixed schedule, though an accelerated priority review or unforeseen early submission could theoretically shift the outcome before year-end.