other material
confidence high
sentiment positive
materiality 0.75
Stoke Therapeutics accelerates EMPEROR enrollment, expects Phase 3 data in mid-2027, cash $391.7M
Stoke Therapeutics, Inc.
- Enrollment of 150 patients in Phase 3 EMPEROR study expected to complete in Q2 2026, accelerated from prior timeline.
- Phase 3 data readout planned for mid-2027; rolling NDA submission to initiate in first half 2027.
- FDA multidisciplinary meeting held; no immediate program changes, but discussions ongoing for expedited pathways.
- Cash, equivalents and marketable securities $391.7M as of Dec 31, 2025; plus Biogen proceeds funds operations into 2028.
- Nearly 330 potential study candidates identified globally; ~60 in screening, ~60 randomized/dosed.