Catalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for Safusidenib in High-grade Glioma. The expected timing is based on the latest available company guidance and may change.
SIGMA/G203 trial. 8/7/25- Updated Ph2 trial design published. 10/23/25- First patient enrolled in Part 2. Provide further updates on progress in earnings call on November 3, 2025. 02/04/26:- Initial data in 2027. 03/02/26:- Phase 2 grade 2 IDH1 glioma data published; ORR 44%, 88% PFS-24mo; SIGMA now pivotal Ph3. 05/04/26:- Acquired Japan rights, now global control. SIGMA pivotal Ph3 data expected 2029; exploratory oligodendroglioma cohort data 2027. 08/06/26:- PR No update. 08/20/26:- FDA granted Fast Track to safusidenib; SIGMA Ph3 enrollment ongoing.
Verification
Confirm timing and program details against the company announcement or filing.