Early-Stage ER-Positive HER2-Negative Breast Cancer
RHHBYRoche HoldingCatalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Giredestrant (Estrogen Receptor Degrader) in Early-Stage ER-Positive HER2-Negative Breast Cancer. The expected timing is based on the latest available company guidance and may change.
02/19/26:- Phase 3 lidERA early-stage ER+ HER2- breast cancer data to be submitted to FDA in coming weeks. 03/09/26:- Phase 3 lidERA data submission to FDA planned in coming weeks. 05/06/26:- Phase 3 lidERA early breast cancer data have been submitted to the FDA; NDA acceptance decision pending. 05/19/26:- LidERA menopausal status results to be presented at ASCO May 30, 2026. 06/02/26:- FDA accepted lidERA NDA; PDUFA Nov 30, 2026. 07/23/26:- lidERA Priority Review was reiterated; FDA decision will occur November 30, 2026.
Verification
Confirm timing and program details against the company announcement or filing.