---
schema_version: "secwatch.filing_event.v1"
accession: "0001689548-25-000114"
form_type: "8-K"
ticker: "PRAX"
cik: "0001689548"
company_name: "Praxis Precision Medicines, Inc."
filed_at: "2025-12-08T23:59:59+00:00"
generated_at: "2026-05-16T13:59:11.200031+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Praxis gains FDA alignment for ulixacaltamide NDA; relutrigine & vormatrigine trials positive

## Summary
- Ulixacaltamide pre-NDA meeting with FDA completed; NDA submission expected early 2026.
- Relutrigine EMBOLD study stopped early for efficacy; 53% placebo-adjusted seizure reduction (p<0.0002) over 16 weeks.
- Relutrigine: 66% increase in motor seizure-free days (p=0.034); no drug-related serious adverse events.
- Vormatrigine RADIANT FOS cohort (n=62): 54% median seizure reduction at 8 weeks; 11% seizure-free for entire 8-week period.
- Vormatrigine POWER1 pivotal study fully enrolled; POWER2 on track for H2 2026; POWER3 monotherapy starts H1 2026.

## SEC filing metadata
- accession: 0001689548-25-000114
- form_type: 8-K
- ticker: PRAX
- cik: 0001689548
- company_name: Praxis Precision Medicines, Inc.
- filed_at: 2025-12-08T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1689548/000168954825000114/0001689548-25-000114-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1689548/000168954825000114/prax-20251204.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001689548-25-000114
- JSON: https://secwatch.observer/filing/0001689548-25-000114.json
- Plain text: https://secwatch.observer/filing/0001689548-25-000114.txt

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