Overview
- An independent data monitoring committee recommended stopping the EMBOLD registrational cohort early based on efficacy.
- The FDA confirmed a meeting in the coming weeks to review the EMBOLD data, after which Praxis will decide on NDA timing for relutrigine.
- Praxis will present topline EMBOLD results on December 6 at the American Epilepsy Society Annual Meeting in Atlanta.
- Praxis shares jumped roughly 25%–31% on Friday as HC Wainwright raised relutrigine’s probability of success to 80% and boosted its price target and peak sales estimates.
- In a separate update, Praxis completed a pre‑NDA meeting for ulixacaltamide for essential tremor and expects to submit an NDA in early 2026.