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Praxis announces accelerated development path for relutrigine in SCN2A and SCN8A DEE patients following positive FDA feedback
PraxisPraxis(US:PRAX) Globenewswire·2025-11-04 21:00

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 ...