Catalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Ifinatamab Deruxtecan (I-DXd) in Small cell lung cancer, Cancer. The expected timing is based on the latest available company guidance and may change.
IDeate-Lung01 trial. 9/7/24 Promising Ph2 data at WCLC2024. 8/18/25- Granted Breakthrough Therapy Designation. 04/13/26:- BLA accepted; Priority Review with PDUFA October 10, 2026 for ES-SCLC post-platinum.
Verification
Confirm timing and program details against the company announcement or filing.