other material
confidence high
sentiment positive
materiality 0.75
Praxis reports positive EMBRAVE Part A data for elsunersen; FDA grants priority review for relutrigine
Praxis Precision Medicines, Inc.
- Elsunersen achieved 77% placebo-adjusted seizure reduction (p=0.015) in 9-patient Phase 1/2 trial.
- 57% of elsunersen patients had ≥28-day seizure freedom; improvements in sleep, motor function, attention.
- Relutrigine NDA accepted for priority review by FDA with PDUFA target date of September 27, 2026.
- Elsunersen well tolerated; no drug-related SAEs, no discontinuations, no neuroinflammation at doses up to 8 mg.
- All 9 patients continued into open-label extension; efficacy sustained for up to one year.