---
schema_version: "secwatch.filing_event.v1"
accession: "0001689548-25-000086"
form_type: "8-K"
ticker: "PRAX"
cik: "0001689548"
company_name: "Praxis Precision Medicines, Inc."
filed_at: "2025-07-17T23:59:59+00:00"
generated_at: "2026-05-18T05:58:39.521063+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA grants Breakthrough Therapy Designation for relutrigine in SCN2A/SCN8A DEEs

## Summary
- FDA granted Breakthrough Therapy Designation for relutrigine in pediatric SCN2A and SCN8A DEEs.
- BTD supported by positive data from EMBOLD study cohort 1 and 11-month open-label extension data.
- Company initiated EMERALD study evaluating relutrigine across all DEEs.
- Company entered quiet period ahead of RADIANT Phase 2 topline results expected by mid-2025.

## SEC filing metadata
- accession: 0001689548-25-000086
- form_type: 8-K
- ticker: PRAX
- cik: 0001689548
- company_name: Praxis Precision Medicines, Inc.
- filed_at: 2025-07-17T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1689548/000168954825000086/0001689548-25-000086-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1689548/000168954825000086/prax-20250717.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001689548-25-000086
- JSON: https://secwatch.observer/filing/0001689548-25-000086.json
- Plain text: https://secwatch.observer/filing/0001689548-25-000086.txt

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