/fda-regulationSeptember 19, 2026Corrected regulatory status language. Prior version incorrectly stated that an NDA had been accepted by FDA and that a PDUFA target date existed for retatrutide. As of September 2026, no application has been submitted or accepted. Eli Lilly's current public position is that it plans to submit a Biologics License Application (BLA) for retatrutide in Q1 2027. Updated page language to reflect this accurately.
Source: Eli Lilly Q2 2026 Earnings Release — investor.lilly.com