Praxis Precision Medicines stopped its pivotal EMBOLD Phase 2/3 study of relutrigine in developmental and epileptic encephalopathies early after an interim analysis showed robust efficacy. BioCentury reported the registrational study was halted for efficacy, prompting a sharp market reaction and strengthening the company’s case for regulatory discussions on approval. Company releases and investor notes indicated the data could form the backbone of a submission to the FDA, while analysts flagged the potential for accelerated regulatory pathways if the benefit is sustained and safety is acceptable. Clarification: early stopping for efficacy occurs when a preplanned interim analysis demonstrates a treatment effect strong enough to meet predefined statistical thresholds; regulators consider the totality of data before making approval decisions.