# Praxis Precision Medicines Receives FDA Breakthrough Therapy Designation for Elsunersen for the Treatment of Seizures Associated with SCN2A Developmental and Epileptic Encephalopathy Caused by Gain of Function Variants
Canonical URL: https://biopharmsignal.com/news/PRAX/praxis-precision-medicines-receives-fda-breakthrough-therapy-designation-for-elsunersen-for-the-treatment-of-seizures-associated-with-scn2a-developmental-and-epileptic-encephalopathy-caused-by-gain-of-function-variants
Ticker: PRAX
Company: Praxis Precision Medicines
Source: Praxis Precision Medicines
Published: 2026-06-25 13:46 EST
Original Source URL: https://investors.praxismedicines.com
## Summary

The Breakthrough Therapy Designation (BTD) was granted based on the positive results from the EMBRAVE Part A trial of elsunersen Elsunersen demonstrated a 77% sham-adjusted reduction in monthly seizures (p=0.015), with benefit sustained in the open-label extension for up to one year The pivotal

## Article Body
The Breakthrough Therapy Designation (BTD) was granted based on the positive results from the EMBRAVE Part A trial of elsunersen Elsunersen demonstrated a 77% sham-adjusted reduction in monthly seizures (p=0.015), with benefit sustained in the open-label extension for up to one year The pivotal
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