Praxis announces accelerated development path for relutrigine in SCN2A and SCN8A DEE patients following positive FDA feedback
Comprehensive meeting with FDA conducted in Q3 in conjunction with Breakthrough Therapy Designation Key aspects of a potential NDA application discussed and aligned with the Agency Praxis plans to perform an interim analysis of the EMBOLD cohort 2 pivotal trial in Q4 2025, which if positive should serve as the basis of an NDA in early 2026 BOSTON, Nov. 04, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into t ...