Praxis Precision Medicines stopped its Phase 2/3 EMBOLD trial early after an interim analysis showed sufficient efficacy for relutrigine in developmental and epileptic encephalopathies (DEEs). The registrational study crossed efficacy boundaries, prompting the company to advance regulatory planning and catalyze a sharp increase in its stock price. BioCentury and other outlets reported the early stop was based on robust seizure reductions and consistent benefit across disease severities. Praxes’ move accelerates the path toward potential filing and sets up a regulatory conversation about single pivotal trials and trial designs for rare epilepsy indications. Regulatory officials typically scrutinize early stops for statistical robustness and long‑term durability; companies often follow with confirmatory data or additional cohorts to support label claims.
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