<p>Praxis Precision Medicines Inc. announced that the U.S. Food and Drug Administration has agreed to the company’s proposed changes to the EMBRAVE3 registrational trial for elsunersen in early-onset SCN2A developmental and epileptic encephalopathy (DEE). The trial has been converted from a double-blind, sham-controlled design to a single-arm, baseline-controlled study, reducing the enrollment target from 40 to 30 patients. All participants will receive elsunersen for 24 weeks, followed by an open-label extension. The primary analysis will focus on the change from baseline in countable motor seizures. Enrollment in EMBRAVE3 is accelerating, with topline results expected in 2026. Additionally, topline results from the ongoing EMBRAVE study (Part A, n=9) are anticipated in the first half of 2026. No study results have been presented yet. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Praxis Precision Medicines Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9599557-en) on December 09, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)</p>

PRAX

<p>Praxis Precision Medicines Inc. announced FDA approval to convert the EMBRAVE3 trial for elsunersen in SCN2A-DEE to a single-arm study, reducing enrollment from 40 to 30 patients. Participants will receive elsunersen for 24 weeks, with results expected in 2026. This change aims to accelerate enrollment and focus on motor seizure changes.</p>

Praxis Precision Medicines Converts EMBRAVE3 Trial to Single-Arm Study for Elsunersen in SCN2A-DEE