Catalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Pirtobrutinib in Chronic lymphocytic leukemia (CLL). The expected timing is based on the latest available company guidance and may change.
BRUIN CLL study: 11/23- Topline data reported. Presentation at ASH 2023. 11/5/24 Present additional update at ASH '24 on 12/9. 9/8/25- Announced topline results from BRUIN CLL-313 study. 12/09/25:- BRUIN CLL-313 Ph3 detailed PFS and safety data at ASH 2025. Regulatory submissions begun; approvals hoped in 2026. 06/02/26:- BRUIN CLL-322 Ph3 PFS results to be presented at EHA June 12-14, 2026. 06/26/26:- CHMP positive opinion for EU CLL expansion; EC decision in 1-2 months. FDA decision expected H2 2026.
Verification
Confirm timing and program details against the company announcement or filing.