Inluriyo (imlunestrant) + Verzenio (abemaciclib) was approved by the FDA on September 18, 2026 for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, in combination with abemaciclib.
Verified against: FDA action day September 18, 2026 (NDA 218881 S-001) · Announcement September 18, 2026 (sponsor announcement) · Goal date none sourced.
Inluriyo (imlunestrant) approved in combination with Verzenio (abemaciclib) for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer (Sep 18 2026).
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.
Primary source: FDA approval notification, September 18, 2026 (CDER)
FDA record of the action: the FDA approved on September 18, 2026, per NDA 218881 S-001 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA 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 FDA approved the application for Inluriyo (imlunestrant) with Verzenio (abemaciclib) on September 18, 2026, per the FDA's own record. The primary source is linked on this page.
Inluriyo (imlunestrant) with Verzenio (abemaciclib) is an Eli Lilly and Company (LLY) program. The FDA decision came on September 18, 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 +17.2%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.