Inluriyo (imlunestrant) approved in combination with Verzenio (abemaciclib) for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer (Sep 18 2026).
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (3/16/26) through T+0. Run-up high $1280.34 on 8/19/26, low $851.21 on 4/29/26 (T-120 to T-1). FDA decision 9/18/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-09-18
OutcomeApproved
Drug / candidateInluriyo (imlunestrant) with Verzenio (abemaciclib)
IndicationER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
CompanyEli Lilly and Company
Market-cap tierLarge
120-day run-up (T-120→T-1)+17.2%
Cohort decision-day move (history)1.0% median (n=834)
We do not state a goal date for this application. Lilly published no PDUFA target action date for the supplement, and this archive carried no row for it before the approval, so the only date we can source is the FDA's action date of September 18, 2026. For that reason the decision is excluded from our decision-timing statistic, which measures FDA action against a sponsor-stated goal date. Inluriyo was first approved on September 25, 2025 as monotherapy under NDA 218881; this is a label expansion resting on the Phase 3 EMBER-3 trial.
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.
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