Mounjaro (tirzepatide) was approved by the FDA for reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease (SURPASS-CVOT); the approval was announced on August 27, 2026.
The FDA approved a new Mounjaro indication to reduce the risk of major adverse cardiovascular events, based on the SURPASS-CVOT trial comparing tirzepatide with dulaglutide.
The FDA's letter for NDA 215866 supplements 44 and 45 is dated August 27, 2026 (FDA letter). It approves updates to the prescribing information based on trial I8F-MC-GPGN (SURPASS-CVOT), the effect of tirzepatide versus dulaglutide on major adverse cardiovascular events in patients with type 2 diabetes, including a new indication to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke). Lilly stated no goal date for this supplement, so no early or late margin is published. This calendar carried the application as a pending "Q4 2026 (est.)" row with no source until a review on November 1, 2026; it is recorded here from the FDA's own letter.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: FDA approval letter, NDA 215866 S-044/S-045
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| OrbiMed Advisors | 257,900 | $309.3 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Yes. The approval of the application for Mounjaro (tirzepatide) was announced on August 27, 2026; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.
Mounjaro (tirzepatide) is an Eli Lilly (LLY) program. The company announced the FDA decision on August 27, 2026; the FDA's own record of the decision is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), LLY moved +20.1%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.