The FDA placed a clinical hold on enrollment in Newron Pharmaceuticals’ U.S. Phase 3 schizophrenia trial ENIGMA-TRS 2 after a patient death occurred outside the country. Newron said the sudden death was considered unrelated to evenamide treatment, and an independent safety monitoring board advised that the study continue as planned. The trial aims to enroll about 400 patients across the U.S., Argentina, India and other countries, testing evenamide, an orally administered small molecule that blocks sodium channels as an adjunctive therapy for treatment-resistant schizophrenia. Newron said it has another Phase 3 evenamide trial (ENIGMA-TRS 1) recruiting in Europe, Canada, Latin America and Asia and reiterated that mortality patterns to date do not show an increased risk versus placebo based on treatment duration.