Catalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Giredestrant in ER-positive advanced breast cancer. The expected timing is based on the latest available company guidance and may change.
9/22/25- Presented results. Data will be presented at an upcoming medical meeting. 02/07/26:- evERA phase 3 in advanced ER+ breast cancer reported positive results at ESMO 2025. 02/19/26:- FDA accepted NDA for evERA giredestrant+everolimus; PDUFA December 18, 2026; OS follow-up ongoing. 05/06/26:- evERA Ph3 showed 44% and 62% PFS risk reductions versus standard endocrine therapy in ITT and ESR1-mutated groups. 05/18/26:- EvERA post-progression analyses presented at ASCO May 31, 2026.
Verification
Confirm timing and program details against the company announcement or filing.