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LLY PDUFA Date: Tirzepatide

FDA decision (PDUFA) target 2026-12-31 · Eli Lilly and Company · Cardiovascular outcomes
More Cardiovascular FDA decisions →All December 2026 PDUFA dates →

The story

Tirzepatide is under FDA review to treat reducing heart-attack and stroke risk in people on tirzepatide (a cardiovascular-outcomes label for the GLP-1/GIP drug).
Full PDUFA calendar ->Every upcoming FDA decision date, by monthIONS-olezarsen . 2026-06-30Same area: Metabolic / Cardio . OlezarsenMRK-winrevair . 2026-09-21Same area: Metabolic / Cardio . WINREVAIR (sotatercept-csrk)EXEL . 2026-12-03Same month decision . XL092 with atezolizumab
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

LLY run-up into the PDUFA (last ~120 days)

$1160.95$851.21
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-12-31
Drug / candidateTirzepatide
IndicationCardiovascular outcomes
CompanyEli Lilly and Company
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.gov—

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FAQ

When is the LLY PDUFA date?
The FDA PDUFA target date for LLY (Eli Lilly and Company) is 2026-12-31 for Tirzepatide. Dates are company/FDA-sourced and can slip — verify against primary filings.
What is LLY's drug Tirzepatide?
Tirzepatide is Eli Lilly and Company's candidate under FDA review for Cardiovascular outcomes.
What typically happens to a large-cap stock into a PDUFA date?
Historically, large-cap names had a median decision-day move around ±1% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.