Inluriyo (imlunestrant) is an ELI LILLY & Co program in ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, in combination with abemaciclib. The FDA approved it on Sep 18, 2026. 2 FDA decisions on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
FDA approval tracked on pdufa.bio: ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, in combination with abemaciclib (approved Sep 18, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: ELI LILLY & Co (LLY). Approval record: Label expansion for Inluriyo, originally approved 2025-09-25 as monotherapy (NDA 218881). The combination approval with Verzenio (abemaciclib) rests on the Phase 3 EMBER-3 trial. Market-cap tier at the time we tracked it: Large. We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
| 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.
No upcoming catalyst is on our calendar for Inluriyo (imlunestrant); 2 FDA decisions are on record below.
On Sep 18, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records Inluriyo (imlunestrant) is FDA-approved for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, in combination with abemaciclib (approved Sep 18, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
ELI LILLY & Co (LLY).
Yes. The FDA approved an application for Inluriyo (imlunestrant) on Sep 18, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.