---
schema_version: "secwatch.filing_event.v1"
accession: "0001689548-25-000116"
form_type: "8-K"
ticker: "PRAX"
cik: "0001689548"
company_name: "Praxis Precision Medicines, Inc."
filed_at: "2025-12-11T23:59:59+00:00"
generated_at: "2026-05-16T13:31:08.531052+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001689548-25-000116
- form_type: 8-K
- ticker: PRAX
- cik: 0001689548
- company_name: Praxis Precision Medicines, Inc.
- filed_at: 2025-12-11T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1689548/000168954825000116/0001689548-25-000116-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1689548/000168954825000116/prax-20251209.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001689548-25-000116
- JSON: https://secwatch.observer/filing/0001689548-25-000116.json
- Plain text: https://secwatch.observer/filing/0001689548-25-000116.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.