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Praxis Precision Medicines Announces Alignment with FDA on Simplified and Accelerated Registrational Pathway for Elsunersen in Early Onset SCN2A Developmental and Epileptic Encephalopathy
Globenewswireยท 2025-12-09 21:01
Clear recognition of high unmet need and urgency for the SCN2A community and plausibility of the mechanism of elsunersen FDA agreed to proposed changes to the EMBRAVE3 trial design to be a single-arm, baseline-controlled study Enrollment in EMBRAVE3 is quickly accelerating and topline results expected in 2026 Topline results from ongoing EMBRAVE study (Part A, n=9) expected in 1H 2026 BOSTON, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceuti ...