Praxis gets FDA nod to simplify EMBRAVE3 study; relutrigine NDA on track for early 2026

Praxis Precision Medicines, Inc.

FDA agreed to convert EMBRAVE3 from double-blind to single-arm baseline-controlled study, enrolling 30 patients (down from 40).
Primary analysis will be change from baseline in countable motor seizures; all screening patients now assigned to elsunersen.
EMBRAVE Part A (9 patients, 3:1 randomization) topline results expected in first half of 2026.
FDA confirmed that Praxis can file a New Drug Application for relutrigine in SCN2A and SCN8A DEEs in early 2026.

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