Shares of Praxis Precision Medicines, Inc. (PRAX) are up over 20% at $234.00 in premarket trading, after the Data Monitoring Committee recommended early stopping of the EMBOLD study of Relutrigine based on interim efficacy results from the registrational cohort.
The company expects to share topline results of the EMBOLD study at the American Epilepsy Society Annual Meeting on December 6, 2025.
EMBOLD is a phase II trial of the company's drug candidate Relutrigine in patients with early onset SCN2A-developmental epileptic encephalopathy (DEE) and SCN8A-DEE. The study included 2 Cohorts - Cohort 1 & registrational cohort.
Data from cohort 1 of the Phase 2 EMBOLD study, reported last September, demonstrated a well-tolerated safety profile with robust, short- and long-term improvement in motor seizures in a heavily pre-treated population, alongside maintained seizure freedom in some patients with SCN2A- and SCN8A-DEE, according to the company.
The company plans to meet with the FDA in the coming weeks to review the data and discuss next steps. The timing for filing an NDA for Relutrigine will be decided after the meeting.
When we alerted readers to PRAX on June 4, 2025, it was trading around $41.
The stock closed yesterday's trading at $189.97, up 2.05%. On Friday, in the pre-market, the shares are trading 23.18% higher at $234.
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