Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer
RHHBYRoche HoldingCatalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Giredestrant (GDC-9545) (Estrogen Receptor Degrader) in Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer. The expected timing is based on the latest available company guidance and may change.
02/20/26:- Phase 3 lidERA early breast cancer data to be submitted to regulators 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. 05/18/26:- LidERA Ph3 menopausal-subgroup results 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.