other material
confidence high
sentiment positive
materiality 0.60
Praxis Precision updates clinical pipeline at R&D Day; ulixacaltamide NDA plan 2025
Praxis Precision Medicines, Inc.
- Ulixacaltamide: 55% vs 31% patients achieved ≥3-point mADL11 improvement (p=0.023) in Essential1.
- FDA confirmed mADL11 as primary endpoint for Phase 3 Essential3; NDA submission expected in 2025.
- PRAX-222 EMBRAVE Part 1 dosing nearly complete; no treatment-related SAEs; 44% median seizure reduction.
- PRAX-628 Phase 1 data show sustained brain activity; Phase 2 PPR study results expected Q4 2023.
- PRAX-562 EMBOLD study ongoing; topline results from pediatric epilepsy study expected H1 2024.